BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ABC R/U HANDPIECE NOZZLE

    MDR report key: 9890252 · Received March 27, 2020

    Report

    Report Number
    3007305485-2020-00119
    Event Type
    Malfunction
    Date Received
    March 27, 2020
    Report Date
    May 12, 2020
    Manufacturer
    CONSOLIDATED MEDICAL EQUIPMENT
    Product Code
    HAM
    PMA / PMN Number
    K871435
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED THREE 130343 IN UNOPENED ORIGINAL PACKAGING. LOT NUMBER WAS VERIFIED. PERFORMED A VISUAL INSPECTION OF THE DEVICE, THERE WERE NO OBVIOUS SIGNS OF A BREACH. PERFORMED A FUNCTIONAL INSPECTION, THE DEVICES WERE DYE LEAK TESTED, WHICH INDICATED THAT THE PACKAGING HAD AN INSUFFICIENT HEAT SEAL ON TWO OUT OF THE THREE PACKAGES. 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 WERE 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 8 COMPLAINTS REGARDING 11 DEVICES FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THE SAME TIME FRAME 201,218 DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED, THE RATE OF FAILURE WOULD BE .00005 PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING; - CONMED ENCOURAGES THE INSPECTION AND/OR TEST OF ALL MEDICAL EQUIPMENT PRIOR TO USE TO ENSURE ALL DEVICES ARE FUNCTIONING AS EXPECTED. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Additional Manufacturer Narrative · 1

    THE REPORTED DEVICE IS BEING RETURNED TO CONMED FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.

    Description of Event or Problem · 1

    THE DISTRIBUTOR IN (B)(6) REJECTED 130343, ABC HAND PIECE NOZZLE, DUE TO AN "INSUFFICIENT HEAT SEAL". IN THIS INSTANCE, THERE WAS NO PATIENT INVOLVEMENT AS THE PACKAGING ANOMALY WAS DISCOVERED DURING INCOMING INSPECTION PRIOR TO DISTRIBUTION TO AN END-USER. THIS REPORT IS BEING RAISED BASED ON DEVICE MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354213 ABC R/U HANDPIECE NOZZLE NOZZLE HAM CONSOLIDATED MEDICAL EQUIPMENT 201808154

    Patients

    Seq Age Sex Outcome Treatment
    1