BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDLINE RENEWAL REPROCESSED TOURNIQUET CUFF

    MDR report key: 6088205 · Received November 8, 2016

    Report

    Report Number
    3032391-2016-00037
    Event Type
    Malfunction
    Date Received
    November 8, 2016
    Date of Event
    September 16, 2016
    Report Date
    November 8, 2016
    Manufacturer
    MEDLINE RENEWAL
    Product Code
    KCY
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IN QUESTION WAS RETURNED TO MEDLINE RENEWAL FOR EVALUATION, AND WE CONFIRMED THAT IT WAS A MEDLINE RENEWAL REPROCESSED ZIMMER TOURNIQUET CUFF, MODEL 60-7075-106. WE PERFORMED A THOROUGH INSPECTION AND INVESTIGATION INTO THE INCIDENT. OUR INVESTIGATION CONFIRMED THAT THE TOURNIQUET IN QUESTION DID HAVE AN AIR LEAK AND WOULD NOT HOLD PRESSURE. MEDLINE RENEWAL TESTS AND INSPECTS EVERY DEVICE FOR PROPER FUNCTIONALITY; THEREFORE THE ROOT CAUSE OF THE FAILURE IS UNKNOWN AT THIS TIME. ALTHOUGH NO PATIENT HARM WAS REPORTED, DUE TO THE PROCEDURAL DELAY TO OBTAIN ANOTHER DEVICE, MEDLINE RENEWAL IS FILING THIS MEDWATCH REPORT.

    Description of Event or Problem · 1

    MEDLINE RENEWAL RECEIVED A REPORT INDICATING A REPROCESSED ZIMMER TOURNIQUET CUFF, MODEL 60-7075-106, LEAKED AIR DURING A SURGICAL PROCEDURE. THE REPORT DID NOT INDICATE THAT THE DEVICE FAILURE RESULTED IN PATIENT HARM. ANOTHER DEVICE WAS READILY AVAILABLE TO COMPLETE THE PROCEDURE; THEREFORE NO PATIENT HARM OR ADDITIONAL MEDICAL INTERVENTION WAS REPORTED AS A RESULT OF THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    737702 MEDLINE RENEWAL REPROCESSED TOURNIQUET CUFF PNEUMATIC TOURNIQUET KCY MEDLINE RENEWAL 60-7075-106 301341

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention