Field Safety Notice GBUK Poly Medicure Limited Polyflush pre-filled syringes (ICN 2077)
Important Customer Notice Field Safety Notice
Ref: 2023/2077 ICN Number: 2077
- Poly Medicure Limited has issued a Field Safety Notice to inform customers of the potential risk that the single sterile content version of Polyflush syringe saline solution 0.9% pre-filled syringe may be mistaken for a muscle relaxant syringe with a similar appearance.
- The products are currently being supplied with a red label which can be confused with other drugs already in use.
- Please refer to the Field Safety Notice for images of the current Polyflush syringe single sterile label and examples of a muscle relaxant syringe.
- The manufacturer is in the process of changing back to non-red labelled stock, however, whilst these products are in circulation, please be aware when using prefilled syringes to avoid drug errors.
- The products affected are available from NHS Supply Chain:
|NPC||Product Description||Supplier Code / MPC||Route|
|FWC620||Prefilled Syringe Sterile Content 10ml 0.9% Sodium Chloride ribbon pouch – Product currently has a RED label||90318||Stock|
|FWC640||Prefilled Syringe Sterile Content 3ml 0.9% Sodium Chloride ribbon pouch – Product currently has a RED label||90311||Stock|
|FWC658||Prefilled Syringe Sterile Content 5ml 0.9% Sodium Chloride ribbon pouch – Product currently has a RED label||90319||Stock|
- Relevant batch numbers are listed in attachment 2, pages 4 and 5 of the Field Safety Notice.
- Please note syringes with the red labels will continue to be issued via NHS Supply Chain until the manufacturer can supply syringes with the amended label.
- Read and follow the full instructions in the Field Safety Notice and share them with all users of the affected products.
- Complete and return attachment 1 Customer Response Form to email@example.com
- Poly Medicure advise the products are safe, fit for purpose and are performing as intended. The risk identified is due to items being incorrectly selected by end users due to the current labelling of the device. Risk can be minimised/ mitigated by removing the device from the areas where the use and need for muscle relaxants is relevant. Clinical areas include but are not exhaustive to:
- Emergency Departments/ resuscitation rooms
- Operating Theatres
- Anaesthetic departments/ rooms
- Critical care areas/ departments.
- Local risk assessment must be carried out to assess and mitigate the risk.
- Should you have concerns about effectively removing these syringes from critical areas and believe continued use might pose a significant risk within your trust please contact your NHS Supply Chain Customer Service Advisor to arrange a return for full credit (reason code 8 not to specification).
- Please confirm if the quantity of product to be returned is a single pack or unit of issue and batch numbers.
- There are alternative products available from NHS Supply Chain however customers are advised to consult your own clinical experts to ensure suitability for your organisation’s use of these products. Further information on the alternative products will be provided imminently.
- All products are to be returned no later than Friday 14 April 2023.
If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.