BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRAZR SUCTN INSTR C/W CONTRL VENT & OBTU

    MDR report key: 18362916 · Received December 20, 2023

    Report

    Report Number
    1320894-2023-00269
    Event Type
    Malfunction
    Date Received
    December 20, 2023
    Report Date
    December 20, 2023
    Manufacturer
    CONMED UTICA
    Product Code
    GCX
    UDI-DI
    30653405000116
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED FOUR 0033080 IN UNOPENED ORIGINAL PACKAGING. LOT NUMBER WAS VERIFIED. PERFORMED A VISUAL INSPECTION OF THE DEVICES, THERE WERE NO OBVIOUS SIGNS OF ABNORMALITIES OR DEFECTS. PERFORMED A FUNCTIONAL INSPECTION, THE DEVICES WERE DYE LEAK TESTED PER TM-10-217 REV. F WHICH INDICATED THAT THE PACKAGING HAD AN INSUFFICIENT HEAT SEAL ON 1 OUT OF THE 4 PACKAGES. 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 SHOWS A TOTAL OF 4 DEVICES FOR THIS LOT NUMBER AND FAILURE MODE; HOWEVER, ONE WAS CONFIRMED. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 12 COMPLAINTS, REGARDING 20 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 (B)(4). WE WILL CONTINUE TO MONITOR FOR TRENDS THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 0

    DURING INCOMING INSPECTION, THE DISTRIBUTOR REJECTED THIS DEVICE, 0033080, FOR AN INSUFFICIENT HEATSEAL. THERE WAS NO CONTACT WITH THE PATIENT AS THIS WAS FOUND DURING INCOMING INSPECTION. THIS WILL BE REPORTED AS A MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2016731 FRAZR SUCTN INSTR C/W CONTRL VENT & OBTU APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX CONMED UTICA 202208151 30653405000116

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown