Becton Dickinson Groshong Catheter Products (ICN 1269)
Important Customer Notice Field Safety Notice
- Becton Dickinson has issued an update to their Field Safety Notice MDS-21-4027 to include additional clinical advice.
- Please refer to the attached updated Field Safety Notice which now includes:
- For all implanted Groshong PICC using this connector, the connector should be reviewed at the earliest opportunity and where the potential for disconnection is identified the connector changed. In practice, this would be as part of the standard of care when the device is maintained or medication administered.
- Becton Dickinson are also requesting completion of the Customer Response Form (Page 4) and return to BDUKFieldAction@bd.com no later than 30 July 2021.
- Even if you have returned the response form previously, or you no longer have impacted product remaining in stock, or you no longer use the product, it is still important that you return the Customer Response Form for BDs reconciliation purposes with the MHRA.
Recall Ref: 14
- Becton Dickinson (BD) has issued an Advisory Field Safety Notice (FSN) for specific lots of Groshong Catheter Products following customer feedback resulting in identification of two issues with the distal connector.
- The inner diameter of the distal connector may be reduced resulting in the inability to pass the catheter through the connector. See figure 2 on page one of the FSN.
- The catch slot on the distal connector may be deformed resulting in the inability for the distal connector to properly lock onto the associated proximal connector section. See figure 3 on page two if the FSN.
- The health consequences associated with the use of a defective connector include the potential for delays in treatment, device leakage, catheter separation leading to infection and embolization requiring medical intervention.
- These are 10 affected products available from NHS Supply Chain via our eDirect route.
- Please see our Downloads ▼ section to refer to the product listing and Appendix 1 “Impacted Product Codes and Lot Numbers” of the Field Safety Notice.
- Please note that some products are available on a regional basis and may not be available nationally.
Advice for Clinical Users
- As a result of this feedback and to mitigate the occurrence of the lack of locking sensation, BD is recommending:
- For new placements, follow the current instructions for use that accompanies the product and that states:
A tactile, locking sensation will confirm that the two pieces are properly engaged.”
- Following these instructions will provide mitigation as the lack of the locking sensation will signal the clinician to obtain a replacement device.
- If the clinician encounters the issues described in this notification, a Replacement Connector must be used.
- Replacement connector kits will be provided by BD free of charge on receipt of a completed Customer Response Form, Page 3 and 4 of the FSN.
- Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
- Complete and return the Customer Response Form to email@example.com as soon as possible, no later than 22 June 2021.
- Becton Dickinson advise there is no requirement for Customers to return any Groshong Catheter Devices to BD. These products can continue to be used in accordance with the guidance in safety notice MDS-21-4027.
If you have any further questions, please contact your local BD representative, or local BD Office on 01293 606643. Alternately contact your local NHS Supply Chain Customer Service Advisor.