BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERI-GAS 4-100

    MDR report key: 296273 · Received September 12, 2000

    Report

    Report Number
    2110898-2000-00011
    Event Type
    Malfunction
    Date Received
    September 12, 2000
    Report Date
    July 24, 2000
    Manufacturer
    3M CO.
    Product Code
    FLI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A HOSPITAL EMPLOYEE CLAIMED ETHYLENE OXIDE GAS CARTRIDGE WAS LEAKING BEFORE IT WAS INSTALLED IN STERILIZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERI-GAS 4-100 EO-GAS CARTRIDGE FLI 3M CO. NA DEC 99 021

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other