Field Safety Notice Becton Dickinson Connecta Stopcocks Multiple Products (ICN 1863)

MHRA TBC
NHS Supply Chain Reference: 59

Alert:

• The supplier Becton Dickinson has issued a Field Safety Notice following internal checks identifying that the specific product lots (listed in Appendix 1) may present a hole or rupture in the unit blister packaging.
• As a result of this potential defect the sterility of the product may be compromised.
• A potential breach in sterility of the packaging presents a health risk of exposure to microbial contaminants.
• This may lead to the potential introduction of infection into the bloodstream, an injury that requires medical intervention to treat.

Products Affected:

• Of the products affected, three product codes have been supplied by NHS Supply Chain:

NPC	Product Description	Supplier Code / MPC	Route
FVK221	Stopcock with extension set and valve 25cm	394936	eDirect
FVK840	Stopcock 3 way with extension line 50cm	394951	Stocked
FVK958	Stopcock 3 way with injection valve and extension line 100cm	394971	Stocked

• Please note only the lot numbers quoted in the Field Safety Notice are affected.
• Becton Dickinson has identified the root cause and is taking corrective actions to prevent recurrence of this issue.

Next Steps:

• Read and follow the full instructions in the Field Corrective Notice and share with all users of the affected products.
• Identify and quarantine all unused affected BD Connecta™ Stopcocks.
• Contact your NHS Supply Chain Customer Service Advisor with full details of the quantities of affected products in your possession including the lot numbers.
• Your Customer Service Advisor will confirm the details and give you a unique CMS reference number. On receipt of written confirmation of disposal quoting the CMS reference number credit will be raised on your behalf.
• Becton Dickinson advise for devices in situ, they should continue to be maintained and replaced in accordance with the hospital/institution’s normal practices, unless there is a clinical suspicion of an infection related or unrelated to these devices.
• We are currently reviewing alternatives for the products affected and will update this ICN once more information is available.

If you have any further questions, please contact your local NHS Supply Chain Customer Service Advisor.