BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FL-601-97 DISPOSABLE EXTENSION CABLE

    MDR report key: 16673675 · Received April 4, 2023

    Report

    Report Number
    1056553-2023-00001
    Event Type
    Malfunction
    Date Received
    April 4, 2023
    Date of Event
    February 21, 2023
    Report Date
    March 31, 2023
    Manufacturer
    REMINGTON MEDICAL, INC
    Product Code
    DSA
    UDI-DI
    00813079021285
    PMA / PMN Number
    K971968
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 0

    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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    391774 FL-601-97 DISPOSABLE EXTENSION CABLE DISPOSABLE EXTENSION CABLE DSA REMINGTON MEDICAL, INC FL-601-97 2222043 00813079021285

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Male