BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HALYARD QUICK CHECK

    MDR report key: 6185055 · Received December 19, 2016

    Report

    Report Number
    6185055
    Event Type
    Malfunction
    Date Received
    December 19, 2016
    Date of Event
    November 22, 2016
    Report Date
    November 23, 2016
    Manufacturer
    HALYARD HEALTH, INC.
    Product Code
    FRG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    STERILE PROCESSING TECHNICIAN WENT TO USE THE STERILIZATION WRAP TO PREPARE SURGICAL TRAYS FOR STERILIZATION WHEN THEY NOTICED THE WRAP'S TOP LAYER WAS COMING APART FROM THE BOTTOM LAYER OF THE WRAP. THIS CAUSED A DELAY IN STERILIZING THE TRAYS SINCE THEY HAD TO FIND WRAP THAT WORKED. MANUFACTURER RESPONSE FOR STERILIZATION WRAP 48X48, HALYARD* QUICK CHECK* STERILIZATION WRAP (PER SITE REPORTER): THEY HAVE SENT IN REPLACEMENT PRODUCT AND WANT TO PICK UP THE AFFECTED LOT.

    Description of Event or Problem · 1

    STERILE PROCESSING - TECHNICIAN WENT TO USE THE STERILIZATION WRAP TO PREPARE SURGICAL TRAYS FOR STERILIZATION WHEN THEY NOTICED THE WRAP'S TOP LAYER WAS COMING APART FROM THE BOTTOM LAYER OF THE WRAP. THIS CAUSED A DELAY IN STERILIZING THE TRAYS SINCE THEY HAD TO FIND WRAP THAT WORKED. MANUFACTURER RESPONSE FOR STERILIZATION WRAP 48X48, HALYARD QUICK CHECK STERILIZATION WRAP (PER SITE REPORTER): THEY HAVE SENT IN REPLACEMENT PRODUCT AND WANT TO PICK UP THE AFFECTED LOT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    837601 HALYARD QUICK CHECK WRAP, STERILIZATION FRG HALYARD HEALTH, INC. 34147 LT6288000

    Patients

    Seq Age Sex Outcome Treatment
    1