BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOSIGN BIOLOGICAL INDICATOR

    MDR report key: 22548 · Received June 14, 1995

    Report

    Report Number
    MW1006266
    Event Type
    Malfunction
    Date Received
    June 14, 1995
    Date of Event
    June 6, 1995
    Report Date
    June 14, 1995
    Manufacturer
    MDT BIOLOGIC CO.
    Product Code
    FRC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TWO DEVICES CAME OUT OF STERILIZER WITH NO MEDIA INSIDE. ONE VIAL WAS INTACT, THE OTHER WAS NOT. RUN WAS ON STEAM LOAD (270 DEGREES FOR 4 MINUTES.)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOSIGN BIOLOGICAL INDICATOR STERILIZER INDICATOR FRC MDT BIOLOGIC CO. 180595D

    Patients

    Seq Age Sex Outcome Treatment
    1 *