BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3M STERI-GAS EO CARTRIDGES

    MDR report key: 2743201 · Received September 5, 2012

    Report

    Report Number
    2110898-2012-00032
    Event Type
    Injury
    Date Received
    September 5, 2012
    Date of Event
    July 30, 2012
    Report Date
    July 30, 2012
    Manufacturer
    3M HEALTHCARE
    Product Code
    FLI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    PT INFO WAS NOT AVAILABLE. NO OTHER ADVERSE PT EFFECTS WERE REPORTED. IF ADD'L INFO IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. NO EVAL WILL BE PERFORMED.

    Description of Event or Problem · 1

    A 3M TECHNICAL SERVICE ENGINEER RECEIVED INFO FROM A MEDICAL FACILITY THAT TWO EMPLOYEES REPORTED SYMPTOMS FOLLOWING A POSSIBLE ETHYLENE OXIDE (EO) EXPOSURE. THE FACILITY REPORTED THAT ONE EMPLOYEE HAD A COUGH AND THE OTHER EMPLOYEE WAS DIAGNOSED WITH ASPERMIA. THE SYMPTOMS REPORTED HAVE MANY POSSIBLE CAUSES. THE CUSTOMER REPORTED THEY DISCOVERED TWO EMPTY AND ONE HALF-FILLED CARTRIDGES. THERE WERE NO EO ALARMS BECAUSE THE EO MONITOR WAS NEAR THE EO STERILIZER AND THE CARTRIDGES WERE FAR FROM THE MONITOR. PHOTOS OF THE CARTRIDGES SHOW THERE WAS A DEFINITE DENT IN THE RIM THAT WAS LIKELY THE CAUSE OF THE HIGH EMIT RATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3M STERI-GAS EO CARTRIDGES ACCESSORY TO M.D., NOT REGULATED BY FDA FLI 3M HEALTHCARE NA 201606AJ

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other