Supply Issues Rocket Medical Chest Drainage Kits FDB884 and FSW735 (ICN 1809)

• The supplier Rocket Medical can recommence the supply of the products on regulatory hold due to MDD/MDR certification changes.
• Rocket Medical’s certificates have been extended and are therefore now able to place products on the market.
• 11 of the previously affected codes are now  available to order from our online catalogue:
  • FSU383, FDB875, FDB877, FSW564, FFY203, FIC24751, FIC24752, FIC24753, FSW1571, FSW1607 and FSW705.
• One product code remains suspended and unavailable to order:
  • FDB884.
• Six product codes are now delisted and unavailable to order:
  • FFY327, FTC697, FSU387, FSQ2937, FSU384, and FBE10183.
• Seven product codes are affected in total.
• The supply issue is being monitored in conjunction with the supplier. We will continue to review the stock situation to minimise further disruption and update this ICN with the latest information as products become available.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.
• The supply issue is now anticipated to be resolved by 20 October 2023.

• The supplier Rocket Medical can recommence the supply of the products on regulatory hold due to MDD/MDR certification changes.
• Rocket Medical’s certificates have been extended and are therefore now able to place products on the market.
• 37 products are now available to order, and these are shown on the available product listing tab on the product listing.
• Seven product codes are being delisted due to the supplier making these obsolete:
• • FFY327, FTC697, FSU387, FSQ2937, FSU384, FBE10183 and FSU383.
• 11 of the affected product codes remain suspended:
  • FDB875, FDB877, FSW564, FFY203, FIC24751, FIC24752, FIC24753, FSW1571, FSW1607, FSW705 and FDB884.
• The affected product codes will remain suspended, whilst Rocket Medical manufacture new stock.
• The supply issue is being monitored in conjunction with the supplier. We will continue to review the stock situation to minimise further disruption and will update this ICN with the latest information as products become available.
• Potential direct and indirect alternative products are available to order through our online catalogue.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.
• The supply issue is now anticipated to be resolved by 14 July 2023.

• The supplier Rocket Medical has informed us the supply issue is still ongoing.
• The supply issue is now anticipated to be resolved by 7 July 2023.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.

• The supplier Rocket Medical has informed us the supply issue is still ongoing.
• The supply issue is now anticipated to be resolved by 2 June 2023.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.

• The supplier Rocket Medical has informed us that the supply issue across its chest thoracic and related products is still ongoing.
• Five additional product codes are now suspended:
  • FTC697 – Filter suction
  • FDB872- Indwelling Pleural Catheter
  • FSU387 – Chest / thoracic drainage catheter
  • FSW1571 – Chest drain unit
  • FSW1607 – Chest drain unit.
• A total of 52 product codes are affected and are subject to intermittent supply.
• Until stock returns, customers are requested to support with mutual aid requests. This can be fulfilled through liaising with your usual representatives.
• Trusts that are unable to source supply through mutual aid should contact National Supply Disruption Response by calling 0800 915 9964 (free phone number) between 9am and 6pm Monday to Friday or contact your NHS Supply Chain Customer Services Advisor.
• Rocket Medical’s MDD CE certificates have been automatically extended and are therefore now able to place products on the market. The full correspondence for Rocket Medical’s notification is attached to this ICN.
• NHS Supply Chain is working to continue the supply of these products that are now becoming available and further updates will be made via this ICN.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.
• The supply issue is now anticipated to be resolved by 10 May 2023.

• The supplier Rocket Medical has informed us that the supply issue across its chest thoracic and related products is still ongoing.
• 24 product codes are now available to order from our online catalogue.
• One further product code is now affected and is subject to intermittent supply:
  • FTR016 – Nerve Block Needle.
• One product code is subject to Protect Demand Management: These product codes are available to order through NHS Supply Chain. However, trusts are allocated a maximum daily quantity or “threshold” to ensure a fair supply of available stock across the NHS.
  • FSW241 – Collector mid stream urine.
• There are now four product codes available whilst stocks last and when depleted will be delisted from our online catalogue.
  • FSW242 – Collector mid stream urine
  • FST682 – Collector mid stream urine
  • FST683 – Collector mid stream urine
  • FSW242 – Collector mid stream urine.
• Four product codes remain delisted and unavailable to order:
  • FSQ2937, FSU384, FBE10183, FSU383.
• A total of 50 product codes are still affected.
• Of the products affected, there are still 26 products suspended and unavailable to order.
• 24 product codes are available to order but are subject to intermittent supply.
• We have added an updated product listing that shows the status of Chest Drainage product codes.
• Due to this ongoing supply issue product codes will be added to, or removed from, Demand Management based on fluctuating stock levels over the next few weeks.
• Until stock returns, customers are requested to support with mutual aid requests. This can be fulfilled through liaising with your usual representatives.
• Trusts that are unable to source supply through mutual aid should contact National Supply Disruption Response by calling 0800 915 9964 (free phone number) between 9am and 6pm Monday to Friday or contact your NHS Supply Chain Customer Services Advisor.
• Rocket Medical’s MDD CE certificates have been automatically extended and are therefore now able to place products on the market. The full correspondence for Rocket Medical’s notification is attached to this ICN.
• NHS Supply Chain is working to continue supply of these products that are now becoming available and further updates will be made via this ICN.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.
• The supply issue is anticipated to be resolved by 1 May 2023.

• The supplier Rocket Medical has informed us that the supply issue across its chest thoracic and related products are still ongoing.
• 23 product code is now available to order from our online catalogue.
• Two product codes are subject to Protect Demand Management: These product codes are available to order through NHS Supply Chain. However, trusts are allocated a maximum daily quantity or “threshold” to ensure a fair supply of available stock across the NHS.
  • FTK011 – Haemorrhoidal Needle & Syringe
  • FSW241 – Collector mid stream urine.
• Three product codes are now available whilst stocks last and when depleted will be delisted from our online catalogue.
  • FST682, FST683, FSW242.
• Four product codes are delisted and unavailable to order:
  • FSQ2937, FSU384, FBE10183, FSU383.
• A total of 49 product codes are still affected.
• Of the products affected, there are still 37 products suspended and unavailable to order.
• 12 product codes that are available to order but are subject to intermittent supply.
• There are six products subject to Protect Demand Management:
  • FSW076, FSW077, FSW403, FDK557, FTK011, FSW241.
• FSW214 is still currently unavailable to order through our online catalogue as it is subject to Control Demand Management.
• We have added an updated product listing that shows the status of Chest Drainage product codes.
• Due to this ongoing supply issue product codes will be added to, or removed from, Demand Management based on fluctuating stock levels over the next few weeks.
• Until stock returns, customers are requested to support with mutual aid requests. This can be fulfilled through liaising with your usual representatives.
• Trusts that are unable to source supply through mutual aid should contact National Supply Disruption Response by calling 0800 915 9964 (free phone number) between 9am and 6pm Monday to Friday or contact your NHS Supply Chain Customer Services Advisor.
• Rocket Medical’s MDD CE certificates have been automatically extended and are therefore now able to place products on the market. The full correspondence for Rocket Medical’s notification is attached to this ICN.
• NHS Supply Chain are working to continue supply of these products that are now becoming available and further updates will be made via this ICN.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives.
• The supply issue is anticipated to be resolved by 1 April 2023.  

• The supplier has informed us there remain significant stock pressures on Chest Thoracic Seldinger kits, Thoracic Catheters, Ambulatory Bags and Tubing Sets.
• Seven further product codes are now affected:
  • FET1544, FET1547, FIC24751, FIC24752, FIC24753, FFY327 and FFY203
• A total of 49 product codes are now affected.
• Of the products affected, there are 37 products suspended and unavailable to order.
• There are 12 products that are available to order but are subject to intermittent supply.
• Due to this ongoing supply issue, five products are now being threshold managed and are subject to Protect Demand Management.
• These product codes are available to order through NHS Supply Chain. However, trusts are allocated a maximum daily quantity aka “threshold” to ensure fair supply of available stock across the NHS.
  • FSW076 – 1 bottle chest/thoracic drainage system – Single chamber (blue top) 1.8 litre for use with FSW077 and FSW187
  • FSW077 – Tubing set for chest/thoracic drainage systems – Single 1.5m tubing set bottle cap fir tree connector for use with FSW076 and FSW047
  • FSW403 – Chest Thoracic Drainage Kits and Sets – Safety dilator Seldinger kit 12fg with sterile drapes and gown
  • FDK557 – Foetal Scalp Electrode -with connector to fit philips avalon fm30 & fm50 systems
  • FTK011 – Haemorrhoidal Needle & Syringe – 18G x 102mm Black Angled Needle with 10ml Luer Lock Concentric syringe 84mm EtO Sterile.
• One of the affected product codes is currently unavailable to order through our online catalogue as it is subject to Control Demand Management:
  • FSW214 – Chest Thoracic Drainage Kits and Sets Seldinger 12fg.
• If you have an urgent clinical need for the product on Control Demand Management, you need to complete and submit the Control Suspended Consumables Product Submission Webform. See our Useful Links section to access this web form.
• We have added an updated product listing that shows the status of Chest Drainage product codes.
• Due to this ongoing supply issue product codes will be added to, or removed from, Demand Management based on fluctuating stock levels over the next few weeks.
• Until stock returns, customers are requested to support with mutual aid requests. This can be fulfilled through liaising with your usual representatives.
• Trusts that are unable to source supply through mutual aid should contact National Supply Disruption Response by calling 0800 915 9964 (free phone number) between 9am and 6pm Monday to Friday or contact your NHS Supply Chain Customer Services Advisor.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and the potential alternatives.
• The supply issue is still anticipated to be resolved by 21 March 2023.

• The supplier has informed there remains to be significant stock pressures on Chest Thoracic Seldinger kits, Thoracic Catheters, Ambulatory Bags and Tubing Sets.
• There are a total of 42 product codes affected.
• There are now 47 product codes suspended and unavailable to order.
• Due to this ongoing supply issue six product codes are now subject to Control Demand Management
  • FSW077 – Tubing set for chest/thoracic drainage systems – Single 1.5m tubing set bottle cap fir tree connector for use with FSW076 and FSW047
  • FSW076 – 1 bottle chest/thoracic drainage system – Single chamber (blue top) 1.8 litre for use with FSW077 and FSW187
  • FSW047 – 1 bottle chest/thoracic drainage system – Double chamber (green top) 1.8 litre for use with FSW077 and FSW187
  • FSW332 – Tubing set chest/thoracic drainage systems – Y set 2 way with fir tree connectors
  • FSW214 – Chest Thoracic Drainage Kits and Sets – Seldinger 12fg
  • FSW117 – Chest Thoracic Drainage Kits and Sets – Seldinger 12fg.
• Two further product codes are now delisted and unavailable to order.
• Potential alternatives are now available for all delisted product codes.
• We have added an updated product listing that shows the status of Chest Drainage product codes.
• Due to this ongoing supply issue product codes will be added to or removed from Demand Management based on fluctuating stock levels over the next few weeks.
• Whilst changes in availability will be captured by regular updates of this ICN, these fluctuations do cause intermittent availability across the range, resulting in some unavoidable discrepancies in the listing.
• Until stock returns to the online catalogue, customers are requested to support with mutual aid requests. This can be fulfilled through liaising with your usual representatives.
• Trusts that are unable to source supply through mutual aid should contact National Supply Disruption Response by calling 0800 915 9964 (free phone number) between 9am – 6pm Monday to Friday or your NHS Supply Chain customer services advisor.
• If you have an urgent clinical need for any of the suspended product codes, you need to complete and submit the Control Suspended Consumables Product Submission Webform.
• See our Useful Links section to access this web form.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and the potential alternatives.
• The supply issue is anticipated to be resolved by 3 February 2023.

• The supplier has informed there remains to be significant stock pressures on Chest Thoracic Seldinger kits, Thoracic Catheters, Ambulatory Bags and Tubing Sets.
• A further 6 product codes are now affected and unavailable to order.
• There are a total of 45 product codes affected.
• There are 43 product codes suspended and unavailable to order.
• Two product codes are now delisted and unavailable to order. One delisted product code does not have an alternative.
• One product code is available from 26 January 2023.
• Three product codes are available from the 2 February 2023.
• We have added a product listing that shows the status of Chest Drainage product codes.
• Due to this ongoing supply issue these product codes will be added to or removed from Demand Management based on fluctuating stock levels over the next few weeks.
• Until stock returns to the online catalogue, customers are requested to support with mutual aid requests. This can be fulfilled through liaising with your usual representatives.
• Trusts that are unable to source supply through mutual aid should contact National Supply Disruption Response by calling 0800 915 9964 (free phone number) between 9am – 6pm Monday to Friday or your NHS Supply Chain customer services advisor.
• If you have an urgent clinical need for any of the suspended codes, you need to complete and submit the Control Suspended Consumables Product Submission Webform. See our Useful Links section to access this web form.
• See our Downloads ▼ section for Chest Drainage product availability and a full list of product codes subject to Protect Demand Management.
• Sourcing alternatives continues as an urgent requirement and this ICN will be updated as soon as alternatives are available to order on the online catalogue.

• The supplier Rocket Medical has informed us that the supply issue across a range of their products is still ongoing.
• There are now an additional four product codes affected.
• Two product codes have been delisted:
  • FSQ2937 – Catheter thoracic 24FG straight flared end soft
  • FSU384 – Chest / thoracic drainage catheter 20fg adult straight flared end blue stripe hard.
• There are 40 product codes affected in total.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and the potential alternatives.
• Please note:
  • There are significant stock pressures on Chest Thoracic Drains, specifically those used with for the Seldinger technique.
  • There is work ongoing to add to alternatives as an urgent requirement t and this ICN will be updated as soon as alternatives are available to order on the online catalogue.
  • Product codes will be added to or removed from Demand Management based on fluctuating stock levels over the next few weeks.
  • Updates to this ICN be provided.
• The supply issue is anticipated to be resolved by 3 February 2023.

• The supplier Rocket Medical has informed us that the supply issue across a range of their products is still ongoing.
• There are now an additional eight product codes affected.
• There are now 34 product codes affected in total.
• One product code, FDK557 is now being threshold managed and it is subject to Control Demand Management.
• If you have an urgent clinical need for FDK557, you need to complete and submit the Control Suspended Consumables Product Submission Webform. See our Useful Links section to access this web form.
• Potential indirect alternative products are available to order through our online catalogue.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and the potential alternatives.
• The supply issue is anticipated to be resolved by 3 February 2023.

• The supplier Rocket Medical has informed us that the supply issue across a range of their products is still ongoing.
• There are now an additional four product codes affected:
  • FST682 – Collector mid-stream urine without boric with prep wipe uripot
  • FST683 – Collector mid-stream urine without boric with prep wipe urikone sterile single pack
  • FSW239 – Collector mid-stream urine with plastic cone for male use sterile not for use with children
  • FSW241 – Collector mid-stream urine with plastic cone for female use sterile not for use with children.
• There are now 28 product codes affected in total.
• One product code, FTK011 is now being threshold managed as it is subject to Protect Demand Management.
• FTK011 is available to order through NHS Supply Chain. However, trusts are allocated a maximum daily quantity aka “threshold” to ensure fair supply of available stock across the NHS.
• Potential indirect alternative products are available to order through our online catalogue.
• See our Downloads Section to access the product listing for further information on the affected product codes and the potential alternatives.
• The supply issue is anticipated to be resolved by mid-January 2023.

Change:

• The supplier Rocket Medical has informed us of a supply issue across its chest thoracic and related products.
• There are 24 product codes affected.
• This supply issue is due to the transition in Medical Device Regulations, from MDD to MDR certification. Due to the unprecedented volume of medical device manufacturers also making this transition, there is a shortage of auditors to sign off MDR certification, and Rocket Medical is facing the likelihood of a shortage in supply to several of its products.
• Rocket Medical has made the difficult decision to, temporarily, streamline their product offering and increase manufacturing of key lines to ensure a consistent supply where possible.

Impact:          

• The affected product codes are subject to intermittent supply.
• Potential indirect alternative products are available to order through our online catalogue:
• See our Downloads section to access the product listing for further information on the affected product codes and the potential alternatives.
• The supply issue is anticipated to be resolved by 31 October 2022.

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.

Please note that due to the clinical nature of these alternative products we advise you to consult your own clinical experts to ensure suitability for your organisations use of these products.