BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERIFY ASSERT STEAM STERIS

    MDR report key: 15094901 · Received July 22, 2022

    Report

    Report Number
    MW5111090
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    July 19, 2022
    Report Date
    July 21, 2022
    Manufacturer
    STERIS CORPORATION
    Product Code
    OWP
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BIOLOGICAL TESTS RUN FOR AUTOCLAVES RECEIVED FROM MANUFACTURER DEFECTIVE. UNABLE TO DETERMINE DEFECT AS WE HAVE RECEIVED DRIED UP CONTROL CONTAINERS AND BIOLOGICAL TESTS HAVE BEEN FOUND DRY AFTER RUNNING THROUGH LOADS, AND PRIOR TO BEING RUN AS WELL. THESE ARE AFFECTING OUR DAILY PROCESS OF STERILIZING OUR INSTRUMENTS IMPORTANT FOR INFECTION CONTROL. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1356102 VERIFY ASSERT STEAM STERIS BIOLOGICAL STERILIZATION PROCESS INDICATOR WITH RECOMBINANT-DNA PLASMID OWP STERIS CORPORATION LCB033 20230823

    Patients

    Seq Age Sex Outcome Treatment
    1 31 YR Unknown Other