BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M¿ STERI-VAC¿ STERILIZER, 1 DOOR GS8X-1D

    MDR report key: 12840212 · Received November 18, 2021

    Report

    Report Number
    2110898-2021-00068
    Event Type
    Injury
    Date Received
    November 18, 2021
    Date of Event
    October 21, 2021
    Report Date
    January 25, 2022
    Manufacturer
    3M HEALTH CARE
    Product Code
    FLF
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THE STERILIZER WAS EXAMINED AND NO ISSUES WERE FOUND. THE 3M STERI-GAS EO CARTRIDGE LIKELY HAD A PRECONDITIONING FAILURE IN THE STERILIZER. THIS CARTRIDGE FAILURE RESULTED IN AN ERROR ON THE STERILIZER, AND ETHYLENE OXIDE WAS IN THE STERILIZATION CHAMBER WITHOUT THE CARTRIDGE HAVING BEEN PUNCTURED. 3M¿ STERI-VAC¿ STERILIZER, 1 DOOR GS8X-1D2 IS AN INDUSTRIAL DESIGN THAT IS NOT REGULATED AS A MEDICAL DEVICE. THIS REPORT WAS RECEIVED FROM AN INDUSTRIAL CUSTOMER AND NOT FROM A HEALTHCARE FACILITY.

    Additional Manufacturer Narrative · 0

    PATIENT IDENTIFIER, WEIGHT, ETHNICITY, RACE: NOT PROVIDED. THE STERILIZER WAS EXAMINED AND NO ISSUES WERE FOUND. THE 3M STERI-GAS EO CARTRIDGE LIKELY HAD A PRECONDITIONING FAILURE IN THE STERILIZER. THIS CARTRIDGE FAILURE RESULTED IN AN ERROR ON THE STERILIZER, AND ETHYLENE OXIDE WAS IN THE STERILIZATION CHAMBER WITHOUT THE CARTRIDGE HAVING BEEN PUNCTURED.

    Description of Event or Problem · 0

    A LABORATORY EMPLOYEE EXPERIENCED A LIGHTHEADEDNESS AND HEADACHE AFTER ALLEGED EXPOSURE TO ETHYLENE OXIDE FROM A 3M STERI-GAS EO CARTRIDGE THAT OCCURRED AFTER A 3M STERI-VAC STERILIZER, 1 DOOR GS8X-1D DOOR WAS OPENED. AN ERROR MESSAGE APPEARED ON THE STERILIZER (E108) THE NEXT MORNING AFTER THE STERILIZER RAN OVERNIGHT AND AN EMPLOYEE OPENED THE STERILIZER DOOR. AN ETHYLENE OXIDE ALARM SOUNDED. THE EMPLOYEE WAS SENT TO URGENT CARE, WHERE VITAL SIGNS WERE CHECKED AND FOUND TO BE NORMAL. NO MEDICATION OR OTHER TREATMENT WAS PROVIDED. A FOLLOW-UP APPOINTMENT WAS SCHEDULED FOR THE FOLLOWING DAY AND THE SYMPTOMS HAD SUBSIDED. NO ISSUES WERE FOUND WITH THE STERILIZER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1737547 3M¿ STERI-VAC¿ STERILIZER, 1 DOOR GS8X-1D STERILIZER, ETHYLENE-OXIDE GAS FLF 3M HEALTH CARE GS8X-1D

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Male Other