BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERI-GAS 4-100 CARTRIDGE

    MDR report key: 278744 · Received May 19, 2000

    Report

    Report Number
    2110898-2000-00004
    Event Type
    Malfunction
    Date Received
    May 19, 2000
    Report Date
    April 10, 2000
    Manufacturer
    3M CO.
    Product Code
    FLI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER WAS PREPARING TO OPERATE ETO STERILIZER. CUSTOMER REMOVED A CARTRIDGE FROM ITS CARTON IN A WALL MOUNTED STORAGE CABINET. CUSTOMER CLAIMED THAT CARTRIDGE APPEARED TO BE LEAKING. CUSTOMER IMMEDIATELY DROPPED THE CARTRIDGE ON THE FLOOR, LEFT THE ROOM, CLOSED THE DOOR AND NOTIFIED ADMINISTRATION.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other