BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STERIS 40 STERILANT

    MDR report key: 2132644 · Received June 17, 2011

    Report

    Report Number
    3000251274-2011-00021
    Event Type
    Injury
    Date Received
    June 17, 2011
    Date of Event
    May 18, 2011
    Report Date
    June 17, 2011
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K090036
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A TEAM FROM STERIS RESEARCH AND DEVELOPMENT VISITED THE USER FACILITY TO OBSERVE THE REPORTED EVENT. DURING THEIR VISIT, THEY OBSERVED A SMALL QUANTITY OF INERT POWDER RELEASED WHEN THE STERIS 40 STERILANT CONCENTRATE (S40) CUP WAS PLACED INTO THE CUP WELL OF THE TRAY; THE EVENT WAS INTERMITTENT AND DID NOT OCCUR EVERY TIME A CUP WAS PLACED INTO THE CUP WELL. THE INERT POWERED INGREDIENTS FROM THE S40 CUP WERE ANALYZED FOR CONFORMITY TO THE "POUR DENSITY" SPECIFICATIONS. THE RESULTS SHOWED THE INERT POWERED INGREDIENTS WERE WITHIN SPECIFICATION. THE STERIS OBSERVERS NOTED THE SYSTEM 1E OPERATORS WERE WEARING APPROPRIATE PPE WHILE OPERATING THE PROCESSORS INCLUDING GOGGLES, GLOVES, PARTICLE MASKS, AND APRONS. STERIS OBSERVED 15 PROCESSING CYCLES AND IDENTIFIED THAT THE POWDER WAS THE INERT, NON-TOXIC INGREDIENTS IN THE S40 CUP. THE OPERATORS ARE NOT EXPOSED TO THE STERILANT WHICH CONTAINS PERACETIC ACID, THE ACTIVE INGREDIENT IN STERIS 40 STERILANT CONCENTRATE. STERIS CONSIDERS THIS REPORTED EVENT TO BE ISOLATED AND HAS NOT RECEIVED ANY SIMILAR REPORTS OF A POWDER RISING FROM THE SYSTEM 1E CUP TRAY WHEN INSERTING THE STERIS 40 STERILANT CONCENTRATE CUP. THE USER FACILITY WILL EXAMINE AIR MOVEMENT IN THE REPROCESSING ROOM AND DETERMINE IF CHANGES IN THE INCOMING AIR VENT REGISTER WOULD PROVIDE A MORE EFFECTIVE AIR FLOW PATTERN.

    Description of Event or Problem · 1

    THE USER FACILITY OBSERVED POWDER RISING FROM THE SYSTEM 1E CUP TRAY WHEN INSERTING THE S40 STERILANT CUP. HOSPITAL STAFF REPORTED CERTAIN IRRITATIONS SUCH AS BURNING IN THE THROAT, COUGHING, AND HEADACHES. THE OPERATORS HAVE NOT SOUGHT NOR RECEIVED ANY TREATMENT FOR THESE REPORTED IRRITATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS 40 STERILANT STERILANT MED STERIS CORPORATION - HOPKINS

    Patients

    Seq Age Sex Outcome Treatment
    1 Other