BEUDAMED
    FDA Adverse Event Summary report: N

    STERIS S20 STERILANT

    MDR report key: 2222195 · Received August 24, 2011

    Report

    Report Number
    3000251274-2011-00031
    Date Received
    August 24, 2011
    Date of Event
    August 5, 2011
    Report Date
    August 24, 2011
    Manufacturer
    STERIS CORPORATION - HOPKINS
    Product Code
    MED
    PMA / PMN Number
    K875280
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER REPORTED THAT THEIR STERILANT HAD BEEN STORED IN AN AREA THAT DID NOT MEET THE LABELED STORAGE CONDITIONS FOR THE STERIS 20 STERILANT CONCENTRATE. THE FACILITY REPORTED THAT DUE TO A MECHANICAL FAILURE OF THEIR HVAC SYSTEM, THE S20 CONTAINERS WERE EXPOSED TO HIGH TEMPERATURES NOT WITHIN OUR SPECIFICATIONS. THE OPERATOR MANUAL STATES (2-10), "STORE UPRIGHT IN A COOL, DRY PLACE. AVOID EXPOSURE TO EXTREME CONDITIONS SUCH AS HEAT, MOISTURE, SUNLIGHT OR CONTAMINATED SUBSTANCES". STERIS SERVICE TECHNICIAN FOUND THAT AN ADDITIONAL SIX STERIS 20 STERILANT CONCENTRATE CONTAINERS SHOWED SIGNS OF SWELLING AND PROCEEDED TO DISPOSE OF THEM. STERIS SERVICE TECHNICIAN REVIEWED THE PROPER HANDLING AND STORAGE OF STERIS S20 STERILANT CONCENTRATE WITH THE USER FACILITY WHO INDICATED TO THE TECHNICIAN THEIR UNDERSTANDING.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT WHILE AN EMPLOYEE WAS REMOVING A CONTAINER OF STERIS 20 STERILANT CONCENTRATE FROM THE BOX THE STERILANT CONTAINER RUPTURED SUBSEQUENTLY GETTING CONTENTS FROM THE S20 CONTAINER ON HER LOWER TORSO AND UPPER LEGS CAUSING REDNESS TO THE SKIN; NO BLISTERING OCCURRED. THE EMPLOYEE SHOWERED AT THE USER FACILITY SITE THEN WENT TO URGENT CARE AND THE EMERGENCY ROOM WHERE NO FURTHER TREATMENT WAS ADMINISTERED. THE EMPLOYEE RETURNED TO WORK AND IS FINE WITH NO SUSTAINING INJURIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERIS S20 STERILANT STERILANT MED STERIS CORPORATION - HOPKINS 3467C03311

    Patients

    Seq Age Sex Outcome Treatment
    1 Other