BEUDAMED
    FDA Adverse Event Summary report: N

    3017 ETO STERILIZER

    MDR report key: 2388514 · Received June 24, 2010

    Report

    Report Number
    3005899764-2010-00013
    Date Received
    June 24, 2010
    Date of Event
    April 29, 2010
    Report Date
    June 24, 2010
    Manufacturer
    STERIS MEXICO, S. DE R.L. DE C.V.
    Product Code
    FLF
    PMA / PMN Number
    K931872
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED THAT A THIRD PARTY CONTRACTOR THEY HIRED TO CHECK AIR PRESSURE DIFFERENTIALS, AIR EXCHANGES, AND PREFORM EXPOSURE MONITORING FOUND AN OPEN PETCOCK VALVE ON THE FACILITY'S EXHAUST LINE ALLOWING ETHYLENE OXIDE TO BE EXHAUSTED INTO THE STERILIZER SERVICE ROOM. THE CONTRACTOR STOPPED THE LEAK BY CLOSING THE PETCOCK VALVE. THERE WERE NO REPORTED INJURIES AS A RESULT OF THIS EVENT. THE PETCOCK VALVE IS USED TO EMPTY WATER AND DEBRIS THAT MAY HAVE ENTERED THE EXHAUST LINE FROM OUTSIDE SOURCES SO THAT THE WATER AND/OR DEBRIS DOES NOT ENTER INTO THE ETHYLENE OXIDE STERILIZER. THE VALVE IS ATTACHED TO THE EXHAUST LINE WHICH RUNS FROM THE SERVICE ROOM TO THE OUTSIDE OF THE BUILDING. THE USER FACILITY CONCLUDED THE VALVE WAS OPENED INADVERTENTLY BY A FACILITY EMPLOYEE AS IT SITS AT FOOT LEVEL ALONG THE FACILITY EXHAUST LINE A FEW FEET AWAY FORM THE STERIS ETHYLENE OXIDE STERILIZER. STERIS HAD NOT SERVICED THE EQUIPMENT PRIOR TO THE REPORTED EVENT. STERIS HAS DETERMINED THE CAUSE OF THIS EVENT TO BE UNRELATED TO THE STERIS ETHYLENE OXIDE STERILIZER AS THE PETCOCK VALVE LEFT OPEN IS PART OF THE USER FACILITY'S EXHAUST LINE AND IS NOT PART OF THE STERILIZER.

    Description of Event or Problem · 1

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3017 ETO STERILIZER STERILIZER FLF STERIS MEXICO, S. DE R.L. DE C.V. M1301043

    Patients

    Seq Age Sex Outcome Treatment
    1 Other