BD (NYSE:BD) issued a notice in Europe to remove specific lots of its Connecta Stopcock and Nexiva with Connecta from use.
In May, the Franklin Lakes, New Jersey-based company issued a product removal field safety notice and has since identified further lots which may also exhibit a reported defect.
According to a notice dated July 18 but published today by the Federal Institute for Drugs and Medical Devices in Germany, customer feedback confirmed that specific lots of the affected devices may have the potential for leakage at the housing component of the stockpock.
The clinical risk related to the issue includes the potential for delay or interruption of treatment, exposure to infusate and biohazardous material, under dosing or under infusion, contamination and/or air ingress. BD has identified the issue is related to a specific molding cavity used in manufacturing. Corrective actions have been implemented to prevent reoccurrence.
Clinical users are instructed to check if their device falls under the affected lots and to replace it immediately if so. If they are unable to determine if the device is within scope, they should replace it or continue to monitor for leakage and/or other complications.
Additionally, customers should inspect their inventory, then locate and quarantine any units of impacted products. For units destroyed, replacement devices will be sent by BD. If customers have further distributed the product, the facilities to which they were distributed must be identified and notified at once of the product removal so that they can immediately destroy the affected product.