BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EAGLEPAC STERILIZATION POUCHES

    MDR report key: 11086 · Received January 21, 1994

    Report

    Report Number
    MW1000505
    Event Type
    Malfunction
    Date Received
    January 21, 1994
    Date of Event
    January 11, 1994
    Report Date
    January 13, 1994
    Manufacturer
    AMERICAN STERILIZER CO.
    Product Code
    KCT
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WHEN ATTEMPTING TO OPEN STEAM STERILIZATION POUCHES FOR PRESENTATION OF ITEMS TO THE STERILE FIELD, THE POUCHES ARE TEARING DOWN THE MIDDLE INSTEAD OF AT SEALED EDGES WHERE THEY ARE SUPPOSE TO BE OPENED. THIS RENDERS ITEM INSIDE THE POUCH CONTAMINATED AND CANNOT BE USED. THERE HAVE BEEN PREVIOUS INSTANCES OF THIS PROBLEM. SEVERAL OF THE TORN POUCHES WERE GIVEN TO THE CO SALES REP. EVENT DATES 1/11-12/94.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EAGLEPAC STERILIZATION POUCHES KCT AMERICAN STERILIZER CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 *