Becton Dickinson Regional Block Needle (ICN 1165)
Important Customer Notice Field Safety Notice
MHRA: MDA 2020/012/004/291/006
- Becton Dickinson has issued an advisory Field Safety Notice following discovery that the instructions for use (IFUs) shipped with 10 lot numbers of the nerve block needle ref 408348 were missing the appropriate contraindications.
- This Field Safety Notice is providing the contraindications and Becton Dickinson recommends they be applied when using the product. These are:
- These needles should not be used if there is:
Infection at the intended anaesthetic site of entrance
Allergy to the anaesthetic agent
Evidence of a severe coagulation disorder
Abnormal anatomy that would preclude successful placement of the needle
The patient is uncooperative or unable to be positioned adequately.
- Currently the contraindications state: “the risks associated with the use of this device may be increased due to patient physiological characteristics and clinical needs”.
- This needle is available from NHS Supply Chain as NPC FTR127.
- Please see our Downloads ▼ section to refer to the Field Safety Notice for full details of the 10 affected lot numbers.
- Read and follow the full instructions in the Field Safety Notice and share this document with all users of the affected products.
- Please complete the Customer Response form (Page 3) whether you have stock of the product or not and return the completed form to BDUKFieldAction@bd.com no later than January 15 2021.
- Becton Dickinson advise they have ceased manufacture of this needle with immediate effect please see the product listing for details of potential alternatives
- 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.
If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor