BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD

    MDR report key: 4131207 · Received September 22, 2014

    Report

    Report Number
    4131207
    Event Type
    Malfunction
    Date Received
    September 22, 2014
    Date of Event
    January 11, 2014
    Report Date
    September 22, 2014
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FRC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CHANGES IN EXTERNAL CHEMICAL INDICATORS CHANGE COLOR SO STAFF CAN ACCEPT OR REJECT STERILE OR COMPROMISED ITEMS. STAFF RELY ON THIS VISUALIZATION (CHANGE IN COLORS), HOWEVER LACK OF UNIFORMITY AND STANDARDIZATION COULD RESULT IN USING NON-STERILE EQUIPMENT. PLEASE REFER TO ATTACHED PICTURES. FOR EXAMPLE, STEAM TAPE BEFORE STERILIZATION SHOWS YELLOW LINES. AFTER STERILIZATION, YELLOW LINES TURN BROWN. HOWEVER STERRAD TAPE BEFORE STERILIZATION SHOWS RED LETTERS. AFTER STERILIZATION, THE LETTERS ARE BARELY VISIBLE. THE STERRAD CHEMICAL INDICATOR STRIP IS RED BEFORE STERILIZATION, BUT YELLOW AFTER STERILIZATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    588092 STERRAD INDICATOR, BIOLOGIC STERILAZATION FRC ADVANCED STERILIZATION PRODUCTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 * YES, BUT NOT APPLICABLE