FL-601-97 DISPOSABLE EXTENSION CABLE

Additional Manufacturer Narrative

THE RETURNED "OPENED" CABLE WAS TESTED FOR FIT INTO A STANDARD FEMALE CONNECTOR. THIS ONE CABLE DID NOT LOCK INTO PLACE AS DESIGNED, CONFIRMING THE COMPLAINANT'S OBSERVATION. THE ELEVEN "UNOPENED" RETURNED CABLES WERE ALSO FIT TESTED. ALL FIT (LOCKED INTO THE FEMALE CONNECTOR) PROPERLY AS DESIGNED. THIS DEFECTIVE PRODUCT APPEARS TO BE A ONE-TIME EVENT. CORRECTIVE ACTIONS ARE BEING INITIATED TO PREVENT A RECURRENCE.

Description of Event or Problem

COMPLAINANT REPORTED THAT THE ICU STAFF HAD A PROBLEM WITH THE FL-601-97 DISPOSABLE CABLE. IT COULD BE INSERTED INTO THE OUTLET ON THE EPG DEVICE, BUT IT WOULD NOT SNAP INTO PLACE AND REMAIN FIRMLY CONNECTED. ANOTHER DISPOSABLE CABLE WAS ATTACHED AND HAD NO PROBLEMS. AS REPORTED BY USER FACILITY: "PATIENT HAD A TEMPORARY PACEMAKER, AND DISLODGE THE CABLES FROM THE PACER BOX. WHEN THE CABLES WERE TESTED, THEY DID NOT CLICK INTO A LOCK POSITION DUE TO A DEFECT. THE CABLES WERE REPLACED. A 55 YEAR OLD MALE UNDERWENT DOUBLE VALVE AND CORONARY ARTERY BYPASS (B)(6) 2023. TWO TEMPORARY RIGHT VENTRICULAR PACER WIRES WERE IN PLACED, AND CONNECTED TO TEMPORARY PACER BOX AFTER SURGERY." TWELVE CABLES WERE RETURNED TO THE MANUFACTURER BY THE USER FACILITY. THE RETURNED "OPENED" CABLE WAS TESTED FOR FIT INTO A STANDARD FEMALE CONNECTOR. THIS ONE CABLE DID NOT LOCK INTO PLACE AS DESIGNED, CONFIRMING THE COMPLAINANT'S OBSERVATION. THE ELEVEN "UNOPENED" RETURNED CABLES WERE ALSO FIT TESTED. ALL ELEVEN CABLES FIT (LOCKED INTO THE FEMALE CONNECTOR) PROPERLY AS DESIGNED. THE ONE CABLE THAT DID NOT LOCK INTO PLACE APPEARS TO BE A ONE-TIME EVENT IN WHICH THE LOCKING TAB ON THE CONNECTOR SHROUD WAS BENT INWARD SLIGHTLY FROM ITS NORMAL POSITION. CORRECTIVE ACTIONS ARE BEING INITIATED TO PREVENT A RECURRENCE.