BEUDAMED
    FDA Adverse Event Summary report: N

    STEAM AUTOCLAVE TAPE - LATEX FREE

    MDR report key: 845806 · Received April 17, 2007

    Report

    Report Number
    845806
    Date Received
    April 17, 2007
    Report Date
    April 17, 2007
    Manufacturer
    PERFECSEAL, INC./MEDI-PLUS
    Product Code
    FRC
    Report Source
    User Facility report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN THE THREE DIFFERENT TYPES OF STERILIZATION (ETO GAS, STEAM AND HYDROGEN PEROXIDE STERILIZATION) THERE ARE MULTIPLE COLOR CHANGES TO INDICATE THAT THE ITEMS WERE PROCESSED. FOR EACH METHOD AND EACH VENDOR, THERE IS NO STANDARDIZATION OF COLOR CODING FOR THE ARROW, TAPE, PAPER AND INCHECK STERILIZATION PACKAGING INDICATORS. INSTEAD, THERE IS DEPENDENCE ON MEMORIZATION INCREASING THE CHANCE FOR ERROR IN IDENTIFYING THAT STERILIZATION HAS OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STEAM AUTOCLAVE TAPE - LATEX FREE STERILIZATION SYSTEM, INDICATOR FRC PERFECSEAL, INC./MEDI-PLUS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 *