BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ETO 100% CANISTER

    MDR report key: 16583 · Received October 4, 1994

    Report

    Report Number
    MW1003585
    Event Type
    Malfunction
    Date Received
    October 4, 1994
    Date of Event
    September 14, 1994
    Report Date
    September 14, 1994
    Manufacturer
    AMERICAN STERILIZER CO.
    Product Code
    FLF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CO'S REPAIRMAN CAME TO FIX A REPORTED EQUIPMENT PROBLEM. WHEN DOOR OF STERILIZER UNLOCKED, LOAD WAS REMOVED. DEPT ETO ALARMS SOUNDED. RPTR FOUND THE CANISTER OF ETO HAD LEAKED IN THE CHAMBER. IT HADN'T BEEN PUNCTURED. IT LEAKED AROUND THE UNDERSIDE OF THE RIM ON THE CANISTER. THERE WAS NO INDICATION OF ETO IN CHAMBER BEFORE OPENING DOOR, PERSONNEL WAS EXPOSED TO APPROX (17 PPM OF ETO 3 X OSHA LIMIT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ETO 100% CANISTER CANNISTER CONTAINING 1006 MS OF 100% ETO FLF AMERICAN STERILIZER CO. 132003

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Other