Field Safety Notice Becton Dickinson 4Fr Single-Lumen PowerPICC Catheters (SOLO and non-SOLO versions) (ICN 2723)

MHRA TBC

NHS Supply Chain Reference: 60

Update:

• Becton Dickinson (BD) is now conducting a Field Safety Corrective Action to remove specific lots of 4Fr Single-Lumen PowerPICC Catheters.
• BD has conducted a comprehensive investigation and has identified that three lots of resin used to extrude the tubing material exceeded our supplier’s specification for a material property called Melt Flow Index (MFI).
• BD’s investigation has shown that higher MFI could lead to increased material fatigue leaks.
• All of the extruded catheters meet BD specifications for dimensions and mechanical properties; however, BD is removing all product from the field that was extruded from resin that exceeded the supplier specification.
• BD has identified two additional contributing factors to the increase in material fatigue leaks seen on the 4Fr Single Lumen PowerPICCs in some geographies. Each factor must be controlled in order to minimize the failures. Please review the Field Safety Notice for full details.

Products Affected:

• There are a total of seven products affected available from NHS Supply Chain, please refer to the attached product listing.
• Of the seven affected products, specific lots of four products require removing from use:

• NHS Supply Chain has quarantined any affected lots held. Future orders will be fulfilled with unaffected stock.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Cease use and quarantine any unused affected lot numbers of 4Fr Single Lumen PowerPICC.
• Make a note of the lot numbers and immediately destroy all unused affected units.
• Complete and return the Customer Response Form, page 7 of the notice, to BDFieldActions@bd.com by 11 April 2025.
• Upon receipt, BD will process the response, and you will receive replacements for unused products.
• For any questions related to the contents of the FSN, or for queries surrounding replacement products, please contact your local Becton Dickinson representative.
• Where potential alternatives are identified, Customers are advised to consult your own clinical experts to ensure suitability for your organisation’s use of these products.

• Becton Dickinson has advised that the investigation into the infusate leakage issues with 4Fr PowerPICC Catheters will be concluded by 30 April 2025.
• We will update this ICN with the conclusions as soon as these are provided by the supplier.

MHRA TBC

NHS Supply Chain Reference: 60

Alert:

• Further to ICN 2710, Becton Dickinson (BD) has issued an Advisory Field Safety Notice, to inform customers about an observed increase in customer reports related to infusate leakage during infusion. See our Useful links section for details of ICN 2710.
• These leaks are primarily characterised by a transverse and/or circumferential crack in the catheter body on the 4Fr Single-Lumen PowerPICC Catheter (both SOLO and non-SOLO versions).
• The reports received by BD include the following harms occurring related to these leaks:
  • Extravasation, infiltration, interruption to therapy, foreign body embolism, oedema, customer dissatisfaction, bleeding, and pain.
• BD advise these harms may have occurred due to the catheter damage.
• BD advise other potential harms may include, but are not limited to infection, phlebitis, and air embolism.
• BD’s intention of this advisory notice is to inform customers about BD’s investigation related to the reported increase of leaks, to provide clinical guidance for suspected catheter damage and usage of the devices and alternative devices, and the need that the device must be determined by a qualified medical practitioner, and its use and maintenance must follow product specifications and Instructions for Use.

Products Affected:

• There are seven products affected available from NHS Supply Chain, please refer to the attached product listing for further details on the affected product codes.
• Potential indirect alternative products are available to order through our online catalogue.
• We are currently sourcing further potential alternatives and updates will be made to the product listing as soon as possible.
• The issue is not Lot specific.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes and potential alternatives, and to view the Information for Clinical Choice.
• BD advise there is no requirement for customers to return any devices. These products can continue to be used in accordance with the guidance in the IFU and this advisory FSN.
• If you wish to discuss replacement with alternative devices, please contact your local BD representative.
• For any questions related to the contents of the FSN, or for queries surrounding replacement products, please contact your local Becton Dickinson representative.
• Where potential alternatives are identified, customers are advised to consult your own clinical experts to ensure suitability for your organisation’s use of these products.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor or the Hospital Care team.

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.