Becton Dickinson Venflon Pro Safety Needle Protected I.V. Cannula (ICN 1218)

• We have seen a significant improvement in the supply position for the following product codes:
  FSP5001 – Safety Cannula Ported With Wings Blue 22G x 25mm PUR
  FSP5002 – Safety Cannula Ported With Wings Pink 20G x 32mm PUR
  FSP5003 – Safety Cannula Ported With Wings Green 18G x 45mm PUR
  FSP5004 – Safety Cannula Ported With Wings Grey 16G x 45mm PUR.
• As planned demand management controls will be further relaxed on these codes by 05 August 2021.
• Product code FSP5005 (BD Venflon Pro Safety 14G x 45mm) will remain on demand management until further notice, and we will review the supply position over the next four to six weeks.

• We have seen significant improvement in the supply position of these products and plan to relax demand management controls on these products over the coming weeks.
• Customers should continue to place regular orders to meet their clinical demand.

• Over the next three to four weeks supply will continue to improve for these products
• Demand smoothing measure will need to remain in place during this period to support availability for all NHS trusts
• After this period, we anticipate that the supply pressures will alleviate, however FSP5005 (BD Venflon Pro Safety 14G x 45mm) may need a longer period to full recovery.

• Over the next three to four weeks there will continue to be severe disruption to the supply of these products.
• After this period, we anticipate that the supply pressures will alleviate but demand smoothing measures must remain in place for a further four to six weeks, to support availability for all NHS trusts.

• The stock position of Becton Dickinson 14g and 16g ported safety cannula has now improved.
• Any customers having switched temporarily to an alternative product, can now return to placing demand against the following codes:
  FSP5004 – Safety Cannula Ported with wings Grey 16G x 45mm
  FSP5005 – Safety Cannula Ported with wings Orange 14G x 45mm.
• To maintain availability of the preferred product where clinically required, orders of FSP5004 and FSP5005 are subject to demand smoothing. Orders will be managed in line with current and inbound stock availability. The level of order management is reflective of the totality of all customer requirements and known usage.

• Through further discussions between Becton Dickinson (BD), DHSC, MHRA, NHS England and NHS Improvement, and NHS Supply Chain it has been made clear that supply of BD Pro Safety IV Venflon Cannula sizes 18G and 20G will be severely restricted for the next four to six weeks.
• These products are available through NHS Supply Chain as FSP5002 20g VPS Pink and FSP5003 18g Green.
• Adequate supply of clinically suitable alternative products exists within NHS Supply Chain to support continuity of supply over this period of disruption.
• NHS organisations should follow the MHRA guidance and identify and procure suitable alternative vascular access devices before withdrawing the products identified in the Field Safety Notice.
• Supply of BD products and their alternatives continues to be impacted as a result of continuing high customer demand and insufficient supply into NHS Supply Chain from BD.
• As a result, demand management measures must remain in place to ensure all NHS trusts have access to key consumables with a fair allocation.
• The demand management thresholds are systemically set daily by NHS England and Improvement. The allocation is based on multiple factors with the intention to maintain supply of as much stock as possible to the NHS until normal supply can recommence.
• NHS England and NHS Improvement are not able to increase the threshold levels, allowing more stock to customer, until the stock position improves.  As soon as this is the case then we will notify customers proactively.
• NHS Supply Chain is not able to influence the threshold levels.
• Customers are advised to continue placing demand every day to ensure they get their full weekly allocation and you will be notified by email if your order has been amended.
• We also strongly encourage you to continue following your local procedures for introducing new vascular access devices into clinical areas and ensure that there is adequate supply of alternatives in clinical areas and that clinicians are familiarised with the change.

Alert:

• Becton Dickinson (BD) has identified an issue with specific lots of BD Venflon Pro Safety (VPS) Needle Protected IV Cannulae after identifying an increase in reports of leakage from the injection port.
• BD has issued an updated Field Safety Notice (FSN) and is recalling all products sterilised by ethylene oxide (EtO). It does not affect products sterilised by electron beam.
• Check the FSN for affected product codes and details on how to identify sterilisation methods used.  
• There is a risk of blood or fluid loss from the injection port, which can result in serious harm if undetected.
• Reported issues to date include:
  Minor to severe blood loss
  Delay to treatment
  Failure of cannula leading to replacement
  Non-delivery of critical medications.

Products Affected:

• There are 10 NHS Supply Chain product codes affected, these are available either from our warehouse stocks or via the eDirect route.
• Please refer to the Field Safety Notice and Product Listing for further information on the affected product codes.(See our Downloads ▼ section)

Customer Actions:

• Withdraw and dispose of affected product at the earliest opportunity, ensuring that suitable alternatives are available to maintain care provision.
• Follow the instructions in the Field Safety Notice.
• If you require Becton Dickinson to collect and dispose of your impacted products please indicate this in the customer reply form.
• Circulate the notice to all within your organisation who may use the affected products.
• Follow your local procedures for introducing new vascular access devices into clinical areas.
• Ensure that there is adequate supply of alternatives in clinical areas and that clinicians are familiarised with the change.
• Complete and return the Customer Reply Form on page 3 of the Field Safety Notice to BDUKFieldAction@bd.com  as soon as possible but no later than 7 June 2021. It is important you return this form even if you no longer use the product.
• Contact your local NHS supply Chain Customer Service Advisor with details of destroyed products to enable us to manage any customer credits on your behalf, as appropriate.

Next Steps:

• NHS Supply Chain has created five new NPCs for the stocked products to identify unaffected stock.
• The new NPCs are the same MPC and specifications.
• FSP5001, FSP5002, FSP5003 will be available to order from Wednesday 5 May.
• FSP5004, FSP5005 will be available in coming weeks.
• Where required, potential indirect alternative products are available to order through our online catalogue. Please refer to the Product Listing for information on the new NPCs and alternative products.
• These products will be demand managed with a total weekly threshold that has been set based on existing usage to ensure fair allocation and smooth demand.
• Systemically the thresholds are set daily based on a division of the total weekly threshold to give the daily quantity that can be ordered up to.
• Customers are advised to place demand every day to ensure they get their full weekly allocation.
• Customers will be contacted by Customer Services if their order has been amended.

If you have any further questions, please contact BDUKFieldAction@bd.com, your local NHS Supply Chain Customer Relationship Manager or Customer Services Advisor..

MHRA:  2021/002/018/291/010

NHSSC 85

Alert: 

• Becton Dickinson has issued an urgent Field Safety Advisory Notice affecting the Venflon Pro safety range of Needle Protected I.V. Cannula that have been sterilised by Ethylene Oxide (EtO).
• This advisory notice is due to an increase in the reports for l eakage from the injector port when sterilized by ETO. The identified root cause is due to a modification in the injection port valve dimensions in June 2019 to accommodate EtO sterilization. The issue is seen primarily on the 14-18g devices with lower occurrences on alternative gauge devices.
• The leakage could result in critical clinical impact, if the leakage is undetected for a period, as it has the potential to result in blood loss or inadequate infusion of the infusate and this could result in serious harm or even life-threatening conditions.
• Any failures to date have not resulted in any reported serious patient harm. No specific patient follow up activities are required if the product has already been safely used.

Products Affected:  

• There are 10 NHS Supply Chain product codes affected, these are available either from our warehouse stocks or via eDirect route.
• Please refer to the Field Safety Notice and product listing for further information on the affected product codes.(See our Downloads ▼ section)

Next Steps:   

• Becton Dickinson would like users of the BD Venflon Pro Safety Needle Protected I.V. Cannula to be aware of this potential issue and maintain an increased level of vigilance whilst using these devices that have been EtO sterilized. The method of sterilization can be identified on the product label (refer to Fig 2 and attachment 1 in the Field Safety Notice).
• If possible do not use the injection port in critical situations or where visibility of the device cannot be maintained throughout the procedure.
• Alternately consider placing a second I.V. cannula or use an alternative delivery device or route such as an extension set or three-way stopcock per your clinical judgement based on patient condition and use case.
• If you need to use the injector port:
  When the catheter is inserted in the patient, keep the entire device visible or monitor it for any leakage of blood or fluids from the injection port.
  Pay attention for any leakage after the administration of fluids or medication through the injection port.
• Circulate this safety notice to all in your organisation that may use these devices.
• Complete and return  the Customer Reply Form on page 4 of the Field Safety Notice to BDUKFieldAction@bd.com  no later than 31 March 2021. It is important you return this form even if you no longer use the product.
• There is no requirement for customers to return any BD Venflon Pro Safety Needle Protected I.V. Cannula. The products can continue to be used in accordance with the guidance in the field safety notice.
• Becton Dickinson has revised and implemented corrective actions to the port valve and future product will be sterilised by radiation (E-Beam), which will be denoted by the following symbol on the packaging.
  
• Becton Dickinson confirm the appropriate regulatory agencies have been informed of these actions.
• If you have any further questions, please contact BDUKFieldAction@bd.com or  your local NHS Supply Chain Customer Service Advisor.