Field Safety Notice Smiths Medical Jelco Optiva IV Catheter 5063-AI (ICN 2099)

Alert:

• Smiths Medical has issued an urgent Field Safety Notice to notify customers of a potential defect with the Jelco® Optiva® IV Catheters.
• The supplier has identified the potential for a manufacturing defect within specific lots of the 24-gauge Jelco® Optiva® IV catheters which may result in leakage at the insertion site.
• The potential leakage is the result of catheter damage at proximal end of the catheter and near the tip of the female luer connector.
• A potential concern would be any fluid loss that would disrupt routine fluid delivery, drug delivery or administration of blood.

Products Affected:

•  The affected product is available from NHS Supply Chain Stock route:

• Please note only the two lot numbers listed are affected.
• Affected lots held within NHS Supply Chain have been quarantined and future orders will be fulfilled with unaffected product.

Next Steps:

• Read and follow the full instructions in the Field Safety Notice and share with all users of the affected products.
• Where the affected lot numbers are found cease use and quarantine.
• Contact your local NHS supply Chain Customer Service Advisor with full details of affected products including if the quantity is in boxes of 50 or singles. Your Customer Service advisor will confirm details and provide you with a unique CMS reference.
• On receipt of written confirmation of disposal, in accordance with your local regulations, quoting your unique reference number, credit for the full value of product destroyed will be raised.

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