BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLASH PAK

    MDR report key: 1070767 · Received June 30, 2008

    Report

    Report Number
    1070767
    Event Type
    Malfunction
    Date Received
    June 30, 2008
    Date of Event
    June 27, 2008
    Report Date
    June 30, 2008
    Manufacturer
    SYMMETRY MEDICAL
    Product Code
    KCT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    SMALL FLASHPAK WAS USED TO STERILIZE A SCREWDRIVER FOR A CASE IN PROGRESS. SCREWDRIVER WAS PLACED IN SMALL FLASHPAK WITH INDICTOR IN PACK. INDICATOR DID NOT CHANGE TO BLACK AFTER 5 MINUTE CYCLE. SCREWDRIVER WAS NOT USED.IT SHOULD BE NOTED THAT THE VALVES ON THESE FLASHPAKS WERE RECENTLY REPLACED AFTER A CHANGE IN MFR PROCESS. THIS FLASHPAK HAS THE NEW VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FLASH PAK TRAY, STERILIZATION KCT SYMMETRY MEDICAL * *
    2 COMPLY STERI GAGE INDICATOR INDICATOR, STERILIZATION PROCESS FRC 3M CLASS 5 201305PA

    Patients

    Seq Age Sex Outcome Treatment
    1 *