Becton Dickinson Venovo™ Venous Stent System (ICN 1278)
Important Customer Notice Field Safety Notice
Ref: 2021/1278 ICN Number: 1278
- Becton Dickinson has issued a Field Safety Notice to remove all unexpired lots of Venovo™ Venous Stent System.
- The Venovo™ Venous Stent System has the potential to exhibit deployment issues whereby the proximal end of the stent may not immediately expand upon deployment.
- Over-manipulation or forcing the catheter delivery system in attempts to assist the stent’s expansion could potentially have a varying degree of harm associated with it.
- Potential harm ranges from prolonging the procedure, damaging or deformity of the stent, potential vascular injury, and/or hemodynamic disruption affecting the blood flow and/or a thrombotic event.
- There are 168 product codes previously available via NHS Supply Chain.
- •84 of these product codes are HCTED as noted in the product listing.
- Please refer to the Field Safety Notice and Product Listing for further information on the affected product codes.
- All lots with an expiry date post-April 2021 are within scope. Please refer to Appendix 1 of the notice for Catalogue Numbers/REF’s and Lot numbers shipped by BD to the EMEA market and Appendix 2 identifies the expiry date on the product label.
- The affected product codes are currently unavailable to order, potential alternatives have been identified by the supplier in the product listing.
- Ensure that suitable alternatives are available to maintain care provision, once in place, withdraw and dispose of affected product at the earliest opportunity.
- Follow the instructions in the Field Safety Notice.
- Circulate the notice to all within your organisation who may use the affected products.
- Complete and return the Customer Reply Form on page 3 of the Field Safety Notice to BDUKFieldAction@bd.com as soon as possible but no later than 30 June 2021. It is important you return this form even if you no longer use the product.
- Contact your local NHS Supply Chain Customer Service Advisor with details of destroyed products to enable us to manage any customer credits on your behalf, as appropriate.
If you have any further questions, please contact BDUKFieldAction@bd.com, your local NHS Supply Chain Customer Relationship Manager or Customer Services Advisor.