BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FRAZR SUCTN INSTR C/W CONTRL VENT & OBTU

    MDR report key: 16279060 · Received February 1, 2023

    Report

    Report Number
    1320894-2023-00028
    Event Type
    Malfunction
    Date Received
    February 1, 2023
    Report Date
    March 17, 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

    UPDATE: REPORTED EVENT OF ¿INSUFFICIENT HEATSEAL & (STERILE) POUCH OR BLISTER PACK¿ WAS NOT CONFIRMED DURING THE EVALUATION PROCESS. RECEIVED ONE 0033080 IN UNOPENED ORIGINAL PACKAGING. LOT NUMBER WAS VERIFIED. PERFORMED A VISUAL INSPECTION, THERE WERE NO OBVIOUS SIGNS OF A BREACH IN THE SEAL HOWEVER, THE DEVICE WAS ENCROACHING INTO THE SEAL. PERFORMED A FUNCTIONAL INSPECTION, THE DEVICES WERE DYE LEAK TESTED PER TM-10-217 REV. F WHICH INDICATED THAT THE PACKAGING DID NOT HAVE AN INSUFFICIENT HEAT 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. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF (B)(4)COMPLAINTS, REGARDING (B)(4) 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). THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 0

    THE DEVICE HAS NOT BEEN RETURNED TO DATE AND NO PHOTOGRAPHIC EVIDENCE WAS PROVIDED. THEREFORE, THE REPORTED EVENT CANNOT BE VERIFIED. 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. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. (B)(4). THIS ISSUE WILL CONTINUE TO BE MONITORED 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.

    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
    1403845 FRAZR SUCTN INSTR C/W CONTRL VENT & OBTU APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED GCX CONMED UTICA 0033080 202108161 30653405000116

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown