BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERILCONTAINER

    MDR report key: 5107247 · Received September 28, 2015

    Report

    Report Number
    5107247
    Event Type
    Malfunction
    Date Received
    September 28, 2015
    Date of Event
    September 9, 2015
    Report Date
    September 14, 2015
    Manufacturer
    AESCULAP, INC.
    Product Code
    KCT
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    OVER THE LAST FEW WEEKS, THERE HAVE BEEN SPORADIC EVENTS WHERE THE EXTERNAL CHEMICAL INDICATORS ON OUR ORANGE INDICATOR CONTAINER LOCKS HAVE NOT PROPERLY CHANGED COLOR TO REFLECT THAT STERILIZATION HAS TAKEN PLACE. INTERNAL INDICATOR STRIPS INDICATED STERILIZATION HAD TAKEN PLACE. BIOLOGICAL TESTS HAVE PASSED WITHOUT ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639824 STERILCONTAINER STERILIZATION WRAP CONTAINERS, TRAYS, CASSETTES & OTHER ACCESSORIES KCT AESCULAP, INC. 15051

    Patients

    Seq Age Sex Outcome Treatment
    1