BEUDAMED
    FDA Adverse Event Summary report: N

    ENVIROSYSTEMS ETHYLENE OXIDE STERILANT

    MDR report key: 5021193 · Received August 21, 2015

    Report

    Report Number
    1937531-2015-00009
    Date Received
    August 21, 2015
    Date of Event
    July 23, 2015
    Report Date
    August 21, 2015
    Manufacturer
    STERIS CORPORATION
    Product Code
    FLF
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY OBSERVED THE BOX WAS DAMAGED AND HEAVILY WRAPPED WITH PACKAGING TAPE. THE USER FACILITY REMOVED THE CANISTERS SUBJECT OF THE REPORTED EVENT AND DISPOSED THEM WITHOUT INCIDENT. IT IS LIKELY THE CARRIER SERVICE DAMAGED THE PACKAGE AND ITS CONTENTS DURING SHIPMENT. THE ENVIROSYSTEMS ETHYLENE OXIDE STERILANT'S MATERIAL SAFETY DATA SHEET STATES IN SECTION 6: ACCIDENTAL RELEASE MEASURES, "METHODS FOR CLEANING UP: SPILL SHOULD BE HANDLED BY TRAINED CLEANING PERSONNEL PROPERLY EQUIPPED WITH RESPIRATORY AND EYE PROTECTION. ELIMINATE ALL IGNITION SOURCES. USE WATER TO DILUTE MATERIAL. CONTAIN ANY SPILLS WITH DIKES OR ABSORBENTS TO PREVENT MIGRATION AND ENTRY INTO SEWERS OR STREAMS. SOAK UP SPILLS WITH INERT SOLIDS, SUCH AS CLAY OR DIATOMACEOUS EARTH AS SOON AS POSSIBLE. COMPLY WITH APPLICABLE LOCAL, NATIONAL AND INTERNATIONAL REGULATION." STERIS EMPLOYEES ARE TRAINED TO REJECT OR DISCARD PRODUCT WHICH EVIDENCES SIGNS OF DAMAGE OR DEFORMATION. NO ADDITIONAL ISSUES HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEY RECEIVED A SHIPMENT OF ENVIROSYSTEMS ETHYLENE OXIDE STERILANT WHICH ARRIVED DAMAGED. ONE CANISTER LEAKED DUE TO THE REPORTED DAMAGE. NO REPORT OF INJURY AND NO MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    553582 ENVIROSYSTEMS ETHYLENE OXIDE STERILANT STERILANT FLF STERIS CORPORATION APR15028

    Patients

    Seq Age Sex Outcome Treatment
    1 Other