BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CASTLE ETHYLENE OXIDE GAS STERILIZER

    MDR report key: 35307 · Received July 2, 1996

    Report

    Report Number
    35307
    Event Type
    Injury
    Date Received
    July 2, 1996
    Report Date
    June 29, 1996
    Manufacturer
    CASTLE MDT TECHNOLOGY FOR LIFE
    Product Code
    FLF
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    GAS STERILIZER MALFUNCTIONED, RESULTING IN 3 ITEMS BEING USED IN CARE OF THREE PTS NOT BEING COMPLETELY STERILIZED. CO EXAMINED, REPAIRED AND TESTED THE STERILIZER TO VERIFY APPROPRIATE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CASTLE ETHYLENE OXIDE GAS STERILIZER ETHYLENE OXIDE STERILIZER FLF CASTLE MDT TECHNOLOGY FOR LIFE NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 NA