Becton Dickinson UK Ltd Administration Sets (ICN 1221)

Important Customer Notice Update

Ref: 2021/1221 ICN Number: 1221
  • An updated product listing has been uploaded that shows the latest NPCs that are currently affected.
  • There are four product codes that remain suspended:
    FKA510 – Blood set (twin unvented spike) 2x roll/c in-line drip chamber with 200um filter roll/c alaris safety clamp l/295cm p/30ml 3mm id dehp-free pvc
    FKA080 – Primary set v/u 15 micron Roll/C 2 x SmartSite Y-ports Alaris safety clamp L/255cm P/24ml 3mm id L/F
    FKA516 – Filter set v/u 15um filter pinch clamp 2 x smartsite inj port roll/c alaris safety clamp 1.2um filter l/275cm p/27ml 3mm id dehp-free pvc
    FSB1254 – ALARIS SE Straight blood set 200um prim vol 26ml 275cm.
  • The remaining 58 product codes listed on the product listing are being demand managed.
  • See our Downloads ▼ section for further information on the affected product codes. The suspended codes are highlighted on the Demand Managed file.
  • The recovery of the impacted products is being prioritised based upon demand. Full recovery of the majority of sets is anticipated in the next 4-6 weeks.
  • This ICN will be updated periodically informing providers which sets are now available to all customers to order as normal.
  • 15 of the previously affected Becton Dickinson pump dedicated administration set codes are now in a position where they are fully recovered and can be made available on a national basis.
  • The recovered codes will be available to order on a national basis from 17 May 2021.
  • Please note the products will be demand managed in line with known usage, to maintain availability for all.
  • The original affected codes have been delisted from the catalogue.
  • The recovered codes will remain on demand management to ensure availability for all.
  • The recovered codes have been set as direct alternative products to the original affected codes and are available to order through our online catalogue.
  • See our Downloads ▼ section for further information on the affected product codes.
  • If you have any further questions, please contact your local NHS Supply Chain Customer Relationship Manager or Customer Services Advisor.
  • A further product code has been suspended with immediate effect:
    FSB1254 – Administration set Ivac Signature Edition pump Blood set 2 u/v spikes 2 x roller clamps 200um filter Smartsite Y port L/260cm P/32ml 2.7mm id L/F.
  • See our Downloads ▼ section for further information on the affected product codes. The suspended codes are highlighted on the Demand Managed file.
  • Please note the product codes that are not highlighted on the product listing are being demand managed.
  • One product code is now available to order through our online catalogue:
    FKA716 – Administration set Ivac Signature Edition pump ALARIS SE Straight blood set 200um prim vol 26ml 275cm T.
  • A total of 13 product codes are suspended by the issue.
  • The remaining 48 product codes listed on the product listing are being demand managed.
  • If you have a requirement to order any of the NPCs listed, please escalate this to the Consumables Group lead via the online request form. You can find this in our Useful Links section..
  • A further product code has been suspended with immediate effect:
    FKA516 – Administration set Alaris VP Volumetric pump.
  • See our Downloads ▼ section for further information on the suspended product codes. The suspended codes are highlighted on the Demand Managed file.
  • A total of 13 product codes are suspended by the issue.
  • The remaining 48 product codes listed on the product listing are being demand managed.
  • If you have a requirement to order any of the NPCs listed, please escalate this to the Consumables Group lead via the online request form. You can find this in our Useful Links section.

Change:

  • A further product code has been suspended with immediate effect:
    FKA505 – Administration set Alaris VP Volumetric pump.
  • See our Downloads ▼ section for further information on the suspended product codes. The newly suspended codes are highlighted on the Demand Managed file.
  • One product code is now available to order through our online catalogue:
    FKA058 – Extension set for ivac P7000 variable pressure and 770/711 and Asena cc pumps.
  • 12 product codes remain affected by the issue.
  • If you have a requirement to order any of the NPCs listed, please escalate this to the Consumables Group lead via the online request form. You can find this in our Useful Links section.

Demand Managed Product Update

  • Due to an exceptional increase in national demand for these products, a number of items have been suspended with immediate effect.
  • This is to protect stockholding and allocate volumes as determined by NHS England and NHS Improvement consumption model. It aims to ensure that trusts continue to have access to the consumables they need to provide patient care and to avoid unnecessary risks of stock shortages.
  • Twelve product codes have been suspended and are unavailable to order via our online catalogue.
  • See our Downloads ▼ section for further information on the suspended product codes. The newly suspended codes are highlighted on the Demand Managed file.
  • If you have a requirement to order any of the NPCs listed, please escalate this to the Consumables Group lead via the online request form. You can find this in our Useful Links section.
  • This ICN will be updated when the affected products are reinstated and available to order, or if any additional codes are affected.

Raising credits and disposal

  • Complete and return the response form, page 6 of the Field Safety Notice, and return it to BDUKFieldAction@bd.com.
  • Customers can either dispose of any affected product  or seek replacements directly with the supplier.
  • If you have purchased product via NHS Supply Chain and choose to dispose of affected product, please contact your NHS Supply Chain Customer Service Advisor with full details of all goods disposed to enable us to raise credit on your behalf.
  • If you have purchased affected product directly with Becton Dickinson or would like a replacement please contact BDUKFieldAction@bd.com.

Emergency ordering arrangements for this weekend:

Customer Services will be available to support any emergency requirements between 9am and 5pm Friday 2 April 2021 – Monday 5 April 2021 inclusive. For assistance, please call:

 

Service Team

  • 01623 587 152
  • Becton Dickinson UK Ltd has advised that they have now validated an alternate sterilisation facility and that they are working to bring additional capacity online in April. This will support accelerated recovery of normal supply.
  • The volume of new batches of products supplied should enable prioritised use but will not initially be sufficient to meet full demand on these codes. Becton Dickinson UK Ltd are working to build up supply on the fastest moving and most critical product codes.
  • NHS Supply Chain and Becton Dickinson UK Ltd are putting in place a single supply chain, for the next four to eight weeks. This will distribute the new batches of products that are arriving for NHS England.
  • The single supply chain is being set up to support the controlled reintroduction of new batches of products and to help with the management of stock within trusts. This means that all new batches of stock arriving for NHS England will be distributed via NHS Supply Chain only. There will be no direct supply from Becton Dickinson UK Ltd or any other third-party suppliers for NHS trusts.
  • We want to ensure that as replacement stocks arrive in the system, they can be issued out so that stock impacted by the patient safety alert (which is currently in use), can be withdrawn and replaced at the same time.
  • In consultation with clinicians, it has been agreed that the gradual roll out of the new stock will be based upon usage. Products will be released in a phased manner as the new batches become available. New product codes have been created to support the controlled reintroduction of these products.
  • NHS organisations will be advised when they are allocated the new product codes. Once an organisation receives new product, they will continue to do so. This will assist with planning and avoid the need to return to using products covered by the patient safety alert.
  • Existing products which are covered by the patient safety alert will continue to be available via NHS Supply Chain to maintain continuity of supply.
  • NHS Supply Chain pricing will be available to all NHS organisations and any disparity between direct pricing from Becton Dickinson UK Ltd will be resolved via Becton Dickinson UK Ltd direct with trusts.
  • Once stock levels of the new product batches have returned to normal supply levels, this arrangement will cease. The usual order routes through Becton Dickinson UK Ltd will then become available for use.
  • The devolved administrations will receive products direct from Becton Dickinson UK Ltd.
  • Becton Dickinson UK Ltd Private customers will also receive products direct from Becton Dickinson UK Ltd.

Next steps:

  •  Continue to order existing Becton Dickinson UK Ltd product codes until further clarification is provided on switching your organisation to the new codes. If you have questions or concerns, then please contact your usual Customer Relationship / Account Manager (NHS Supply Chain or Becton Dickinson UK Ltd).
  • Trusts will be provided with at least 24 hours notification that they will be moving to the new codes. Trusts will need to manage the controlled reintroduction of new products into their wards and theatres units alongside the full withdrawal of the corresponding product codes. This will ensure a clean cut over from old to new stock.  Old stock should be quarantined pending further instructions on disposal.
  • To ensure your organisation can identify which product codes are affected by the Field Safety Notice and to view the instructions on how to check the affected lot numbers, please see our Downloads ▼ section/li>
  • You are advised to follow the guidance in the MHRA’s National Patient Safety Alert.
  • Further information will be provided as it becomes available.

Emergency ordering arrangements for this weekend only:

If you need to place emergency orders for clinical and patient requirements during this upcoming weekend, that cannot wait until Monday 29 March, then please contact:

Between 9am and 5pm

Service Team

  • 01623 587 152

Outside of these times

If you have an emergency requirement over the weekend outside of 9am and 5pm, please follow your regular emergency process.

If you have any patient safety concerns, please contact:

patient.safety@supplychain.nhs.uk

 

  • The letter that was issued yesterday from Becton Dickinson UK Ltd states that they have now validated an alternate sterilisation facility and they are working to bring on line additional capacity in April 2021, which will support accelerated recovery of normal supply. The volume of product supplied should enable prioritised use but will not be sufficient to meet full demand on these codes.
  • As replacement stocks arrives in the system this will result in products that are affected by the safety notice as well as new unaffected products being available for use at the same time. To ensure your organisation can identify which products are affected by the Field Safety Notice, please See our Downloads ▼ section to view the instructions to check the lot numbers.

 

Please see the Excel file ‘Product Listing With Alternatives’ for options to help and guide local decision making. The tabs within the spreadsheet contain the following information:

  • Product listing alternatives – options that would not involve changes in clinical practice or additional products
  • Pump to gravity – alternatives suggested are for gravity infusions which is a change in clinical practice from using the current infusion pumps
  • Pump to gravity and accessories – alternatives suggested are for gravity infusions which is a change in clinical practice from using the current infusion pumps. Products on this tab require two products to enable the same infusion to be provided. Both a solution set (either column H or O) needs to be purchased with the accessory in column W
  • Alaris VP to Alaris CC sets – an alternative option proposed by Becton Dickinson is to move to the Alaris CC syringe pump. The product proposed for the alternative option is a dedicated set for use with the Alaris CC pump only.

Whilst reading the spreadsheet, please refer to the red text in the top left hand corner of each tab which will provide you with guidance around the content of that tab.

BD distributed a letter to its customers on 22 March 2021 which is associated with the Field Safety Notification (MDS-21-4072). See our Downloads ▼ section for a copy of the letter to support your local planning.

Update:

  • NHS England and NHS Improvement are encouraging clinicians to use available products (whether BD or alternatives) for indicated purposes only specifically in the cases of specialist oncology and neonatal products.
  • Trusts should use alternative products in line with:
    • The National Patient Safety Alert: Supply disruption of sterile infusion sets and connectors manufactured by Becton Dickinson (BD) (NatPSA/2021/001/MHRA)
    • The operational message issued to trusts concerning issues with supply of Beckton Dickinson (BD) Administration Sets for Volumetric Pumps and Syringe Drivers (Infusion Devices)
    • The Infusion Pump and Syringe Driver – Quick reference user guide issued by NHS England and NHS Improvement.
  • To help support customers, NHS Supply Chain are bringing in 17 products from our eDirect route into stock.
  • Please see Product Listing for a list of the products that are currently being Demand Managed due to this issue.
  • If you have any further questions, please contact your local NHS Supply Chain Customer Relationship Manager or Customer Services Advisor.

Emergency ordering arrangements for this weekend only:

If you need to place emergency orders for clinical and patient requirements during this upcoming weekend, that can’t wait until Monday 22 March, then please contact:

Between 9am and 5pm

Service Team

  • 01623 587 152

Outside of these times
If you have an emergency requirement over the weekend outside of these times, please follow your regular emergency process.

If you have any patient safety concerns please contact:

NHSSC 88

Date:    15/03/2021

  • Becton Dickinson (BD) have notified MHRA that the sterility of some of their devices cannot be guaranteed due to quality issues with their third-party sterilisation provider.
  • BD is recalling all affected stock of the following products:
    Infusion sets for specific Alaris Pumps
    Gravity infusion sets and connectors.
  • Although the devices are likely to be sterile this cannot be guaranteed so there is a very small risk of infection from treatment with these devices. There will be supply disruption whilst BD transfer products to a new sterilisation provider
  • Affected product codes are listed in the Field Safety Notice.
  • The quality issue was recently identified but ongoing for a number of years.
  • The MHRA has issued a National Patient Safety Alert: Supply disruption of sterile infusion sets and connectors manufactured by Becton Dickinson (BD) (NatPSA/2021/001/MHRA) which can be found in our our Useful Links section.
  • The MHRA’s National Patients Safety Alert is for action by: primary and secondary care, blood transfusion services, specialist outpatient settings, oncology providers, hospices, private healthcare.

Products Affected:     

  • There are 63 NHS Supply Chain product codes affected.
  • Please refer to the Field Safety Notice and – the product listing – for further information on the affected product codes.

Next Steps:                                                                       

  • Affected product codes are listed in the Field Safety Notice (FSN). Customers are advised to log into our website to view alternative products. However, customers are reminded that the risks of rapidly changing clinical practice or using unfamiliar devices must be balanced against the risk of continuing to use these BD products as well as the risk of their continuing availability.
  • Public Health England (PHE) has been informed by the Medicines and Healthcare products Regulatory Agency (MHRA) on 10 March of failure of sterilisation quality control over several years affecting devices, predominantly intravenous infusion sets, produced by Becton Dickinson (BD). The PHE Healthcare Associated Infection and Antimicrobial Resistance Division has undertaken a rapid risk assessment comprising review of routine surveillance data and information held by the national opportunistic pathogens laboratory on 11 March. This rapid assessment has not identified evidence of an increase in intravenous line-related infections over the period of concern that might be consistent with a widespread contamination event. A sustained contamination at source that evaded recognition for many years is considered unlikely but small and intermittent contamination events cannot be excluded.
  • This is a safety critical and complex National Patient Safety Alert. Implementation should be coordinated by a senior member of staff e.g. Medical Director supported by Chief Pharmacist, Chief Nurse, Head of Infection Control and Head of Procurement/Supplies or equivalent roles. The Specialist Pharmacy Service (SPS) updated the website with information on using Gravity infusions and bolus injections in adults which can be found in our Useful Links section.
  • Supply disruption is currently to be expected for 4 weeks. Mutual aid of alternative infusion devices and associated consumables is also advised to ensure that clinical risk is minimised. 

Actions to be complete by 31 March 2021 (advised by MHRA notice): 

1.Immediately identify whether your organization uses any of the following ALARIS models pumps:

  • CC
  • GP
  • VP
  • GW/GW800
  • SE
  • IVAC 590 series

2.Use alternative pumps and giving sets or alternatives to intravenous infusion where they are available, and it is safe to do so.

3.Train staff and verify competency before using alternative pumps and ensure training records are updated.

4.Once alternatives are available, remove unused Alaris pump giving sets, gravity infusion sets and connectors from shelves and storage areas and quarantine these devices for later analysis if indicated.

5.If no alternative devices or clinical approaches are available you should:

a) Undertake and document a risk assessment.

b) Follow established local protocols for resource shortage escalation or contingency.

c) Set up systems to ensure that any infections that may be linked to these infusion sets are reported, as appropriate, in your region.

If you have any further questions, please contact your local NHS Supply Chain Customer Relationship Manager or Customer Services Advisor. For any Patient Safety concerns please contact patient.safety@supplychain.nhs.uk.

 

Change: 

  • The supplier Becton Dickinson UK Ltd has informed us of a temporary supply disruption with a range of its Administration Sets.
  • There are 65 NHS Supply Chain product codes affected.
  • The supply issue is due to a production disruption at a third party provider – view the customer letter – for further information.
  • This supply issue is being managed in conjunction with the Department of Health and Social Care’s Strategic Supply Resilience Directorate.

Impact:   

  • Currently all Becton Dickinson UK Ltd’s pump dedicated Administration Sets will be placed on demand management with immediate effect in order to manage stock.
  • The affected product codes on demand management will be reviewed and any potential indirect alternative products will be confirmed. Once we have further information in regard to the alternatives an update to this ICN will be provided.
  • Please refer to the product listing for further information on the affected product codes.
  • The supply issue is anticipated to be ongoing for a number of weeks

Next Steps:          

  • Customers are advised to log into our website to view the potential indirect alternative products.
  • If you have any further questions, please contact your local NHS Supply Chain Customer Relationship Manager or Customer Services Advisor.

Downloads ▼

  • 1221 Becton Dickinson Product Listing 7 June 2021

    An Excel file detailing the affected product codes for ICN 1221.

    Please to view this content.

  • 1221 Becton Dickinson Delisted Products with Alternatives 13 May 2021

    An Excel file detailing the delisted product codes for ICN 1221.

    Please to view this content.

  • 1221 Becton Dickinson UK Ltd Demand Managed Products

    An Excel file detailing the Demand Managed Products for ICN 1221.

    Please to view this content.

  • 1221 Becton Dickinson Customer Letter

    Letter dated 1 April 2021 providing further information for customers relating to this issue.
  • 1221 Becton Dickinson Process to Validate Impacted Sets

    A PDF document of the impacted sets for ICN 1221.
  • 1221 Becton Dickinson UK Ltd Customer Letter

    Letter dated 22 March 2021 providing further information for customers relating to this issue.
  • 1221 Becton Dickinson UK Ltd Product Listing With Alternatives

    An Excel file detailing the alternatives that are available.

    Please to view this content.