BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRAZIER

    MDR report key: 22167516 · Received June 9, 2025

    Report

    Report Number
    1320894-2025-00151
    Event Type
    Malfunction
    Date Received
    June 9, 2025
    Report Date
    June 9, 2025
    Manufacturer
    CONMED UTICA
    Product Code
    GCX
    UDI-DI
    3065340500116
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    REPORTED EVENT ¿INSUFFICIENT HEATSEAL & (STERILE) POUCH OR BLISTER PACK¿ WAS CONFIRMED. RECEIVED 9 OF ITEM 0033080 IN UNOPENED ORIGINAL PACKAGING. PERFORMED A VISUAL INSPECTION OF THE DEVICES AND THERE WERE OBVIOUS SIGNS OF A BREACH FOR FOUR OF THE DEVICES. PERFORMED A FUNCTIONAL INSPECTION ON THE OTHER FIVE DEVICES AND DYE LEAK TESTED THEM WHICH INDICATED THAT ONE OF THE DEVICES HAD PACKAGING WITH AN INSUFFICIENT HEAT SEAL AS THERE WAS LEAKAGE. HOWEVER, THE OTHER FOUR DEVICES THAT WERE DYE LEAK TESTED HAD SUFFICIENT HEAT SEALS AS THERE WAS NO LEAKAGE. A ROOT CAUSE CANNOT BE DETERMINED; HOWEVER, BASED ON THE PHOTOGRAPHIC EVIDENCE, A POSSIBLE CAUSE OF THIS EVENT COULD BE THE DEVICE TIP BREACHED THE SEAL. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. A TWO-YEAR LOT HISTORY REVIEW WAS CONDUCTED AND FOUND A TOTAL OF 9 DEVICES FOR THIS LOT NUMBER; HOWEVER, ONLY 5 WERE CONFIRMED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAVE BEEN A TOTAL OF 32 COMPLAINTS, REGARDING 111 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE 0.00003. WE WILL CONTINUE TO MONITOR PER REGULATORY REQUIREMENTS TO HELP ENSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0033080 SURGICAL SUCTION INSTRUMENT, 8FR W/CONTROL VENT & OBTURATOR, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. PERFORMED A FUNCTIONAL INSPECTION, THE DEVICES WERE DYE LEAK TESTED WHICH INDICATED THAT THE PACKAGING HAD AN INSUFFICIENT HEAT SEAL. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1476973 FRAZIER APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX CONMED UTICA 202306191 3065340500116

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown