BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M STERI-VAC STERILIZER/AERATOR 5XL

    MDR report key: 3608905 · Received January 20, 2014

    Report

    Report Number
    2110898-2014-00004
    Event Type
    Injury
    Date Received
    January 20, 2014
    Date of Event
    December 24, 2013
    Report Date
    December 24, 2013
    Manufacturer
    3M HEALTH CARE
    Product Code
    FLF
    PMA / PMN Number
    K902036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THERE WERE TWO UNITS THAT WERE PLACED ON EACH OTHER. ONE UPPER AND ONE LOWER. THE UPPER UNIT WAS REPORTED TO BE ON ACCELERATED MODE AND HAD A SERIAL NUMBER OF (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A MALE EMPLOYEE WITHIN THE HOSPITAL STERILIZATION FACILITY WAS EXPOSED TO EO WHEN A FEMALE OPERATOR OF THE 3M EO STERILIZER OPENED THE DOOR PRIOR TO FULL AERATION AFTER BEING INFORMED TO ABORT CYCLE. IT WAS REPORTED THE STERILIZER WAS ON ACCELERATED MODE WHEN THE EVENT OCCURRED. THE ACCELERATED MODE SHOULD NOT HAVE BEEN USED FOR A STANDARD STERILIZATION PROCESS FOR THIS MODE IS ONLY APPLICABLE WHEN UNIT IS BEING SERVICED. USER ERROR CONTRIBUTED TO THIS EVENT. THE MALE EMPLOYEE SOUGHT MEDICAL CONSULTATION AT THE OCCUPATIONAL HEALTH CLINIC WITHIN THE HOSPITAL. IT WAS REPORTED THAT THE EMPLOYEE EXPERIENCED A HEADACHE. AT THIS TIME, IT IS NOT KNOWN WHETHER ANY MEDICAL INTERVENTION WAS ADMINISTERED FOR THE HOSPITAL WOULD NOT RELEASE THIS INFO. THE ESTIMATED EXPOSURE TIME TO THE OPERATOR WAS 15 TO 30 SECONDS. THERE WAS ANOTHER INDIVIDUAL (FEMALE OPERATOR OF STERILIZER) AND THIS SUBJECT WAS REPORTED UNDER 2110898-2014-00003. THIS REPORT INCLUDES MORE INFO CONCERNING THE ACTUAL EVENT AND SERVICE INFO. THIS REPORT ONLY COVERS THE MALE SUBJECT REGARDING HIS EXPOSURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46365 3M STERI-VAC STERILIZER/AERATOR 5XL ETHYLENE OXIDE GAS STERILIZER FLF 3M HEALTH CARE 5XL NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other