Field Safety Notice Becton Dickinson BD Connecta™ Stopcocks (ICN 3349)

NHSSC: 15

Alert:

• Becton Dickinson (BD) has issued Field Safety Notice regarding BD Connecta™ Stopcocks.
• Through customer feedback, BD has identified an observed issue in how Port C of the BD Connecta™ Stopcock (Figure 2, page 3 of the notice) operates during use.
• Reports received by BD indicate that when using polypropylene plastic luer lock syringes, the connection at Port C may over thread the syringe and continue to spin.
• BD testing demonstrated a secure connection and did not identify any leakage under clinically relevant simulated conditions related to this issue.
• When tested with polypropylene syringes, Port C showed a lower amount of torque was required to override the syringe threading and cause apparent over-threading of the connection.
• This differing torque during connection and the resulting over-threading may cause user confusion during device use. For this reason, BD is issuing this communication to reinforce important usage recommendations when using BD Connecta™ Stopcock devices.

Products Affected:

• 15 products are affected
• 8 products affected are available via NHS Supply Chain.
• See our Downloads ▼ section to access the product listing for further information on the affected product codes.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice, as per the current Instructions for Use.
• Share with all users of the affected products.
• Compete and return the Customer Response Form, page 7 of the notice, and return to BDFieldactions@bd.com

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

Please be aware that in the event of a Field Safety Notice/Product Recall we may need to provide manufacturers, UK responsible Persons and Distributers with contact details of customers who have potentially received the affected stock. This is to help them to reconcile their stock and evidence to the regulators that all actions have been taken to ensure that the unused products have been removed from customers to prevent inadvertent use of faulty and potentially unsafe products.