BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR

    MDR report key: 6084375 · Received November 7, 2016

    Report

    Report Number
    2084725-2016-00685
    Event Type
    Malfunction
    Date Received
    November 7, 2016
    Date of Event
    October 18, 2016
    Report Date
    October 18, 2016
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FRC
    PMA / PMN Number
    K994055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BRAND NAME - THE CORRECT BRAND NAME IS STERRAD® CHEMICAL INDICATOR STRIP. COMMON DEVICE - THE CORRECT COMMON DEVICE IS INDICATOR, CHEMICAL. CATALOG NUMBER - THE CORRECT CATALOG NUMBER IS 14100_90. LOT NUMBER - THE CORRECT LOT NUMBER IS 132611-01. EXPIRATION DATE - 11/30/2017.

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE CERTIFICATE OF CONFORMANCE (COC)), TRENDING OF LOT NUMBER, AND SYSTEM RISK ANALYSIS (SRA). PER SUPPLIER'S CERTIFICATE OF CONFORMANCE, THE LOT MET ALL PROCESS SPECIFICATIONS BEFORE RELEASE OF PRODUCT. TRENDING ANALYSIS BY LOT NUMBER WAS REVIEWED FROM 04/21/2016 TO 10/18/2016 AND TRENDING WAS NOT EXCEEDED. THE SRA INDICATES THE RISK ASSOCIATED WITH THIS REPORTED QUALITY PROBLEM WITH NO IMPACT ON SAFETY IS CONSIDERED TO BE "LOW." PRODUCT RETURN IS NOT REQUIRED SINCE THERE IS CLEAR AND SUFFICIENT INFORMATION TO DETERMINE USE-ERROR. ADDITIONAL INFORMATION REPORTED BY THE CUSTOMER INDICATED THEY SELF-IDENTIFIED AND RESOLVED THE PROBLEM. PER THE CUSTOMER, "THE INDICATORS WERE CHANGING WHEN WE WOULD RUN TEST CYCLES OF WRAPPED ITEMS, BUT WERE FAILING MAINLY WHEN WE WERE RUNNING BOXED (CONTAINER) LOADS. OUR CONTAINERS ARE PRETTY OLD AND SOME HAVE EXTENSIVE PITTING IN THEM. IT¿S OUR BELIEF THAT THE BOXES WERE ABSORBING THE MAJORITY OF THE HYDROGEN PEROXIDE AND LEAVING INSUFFICIENT AMOUNTS TO PENETRATE THE INTERIOR OF THE BOX AND CHANGE THE INDICATOR. WE HAVE SINCE STOPPED USING OUR OLD BOXES AND HAVE BEEN WRAPPING MOST OF OUR ITEMS. NO PROBLEMS HAVE EMERGED SINCE." PER STERRAD® 100S USER GUIDE GUIDELINES FOR WRAPPING, PACKAGING AND LOADING. NOTE: "IF YOU ARE USING RIGID CONTAINERS CLEARED BY THE FDA FOR USE IN THE STERRAD® SYSTEM, FOLLOW THE SAME PROCEDURES AS ARE RECOMMENDED FOR USE OF THE STERRAD® OR APTIMAX® INSTRUMENT TRAYS. DO NOT STACK INSTRUMENTS INSIDE THE CONTAINERS. DO NOT STACK CONTAINERS. DO NOT STACK CONTAINERS WITHIN CONTAINERS. DO NOT WRAP INSTRUMENTS WITHIN CONTAINER." THE ASSIGNABLE CAUSE OF THE ISSUE CAN BE ATTRIBUTED TO USER ERROR. AS SUCH, CONCOMITANT PRODUCT EVALUATION WAS NOT PERFORMED SINCE THERE IS CLEAR AND SUFFICIENT INFORMATION TO DETERMINE USE-ERROR WHICH IS UNRELATED TO THE STERRAD® UNIT. THE ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A STERRAD CHEMICAL INDICATOR STRIP DID NOT CHANGE COLOR CORRECTLY AFTER A COMPLETED STERRAD 100S CYCLE. THE AFFECTED LOAD WAS NOT RELEASED. THERE WAS NO REPORT OF INFECTION, INJURY OR HARM TO PATIENT(S) ASSOCIATED WITH THIS ISSUE. ALTHOUGH THERE IS NO REPORT OF PATIENT INJURY OR HARM AND NO PRIOR INCIDENTS HAVE RESULTED IN SERIOUS INJURY, ADVANCED STERILIZATION PRODUCTS (ASP) HAS DETERMINED IN THIS SITUATION STERILITY CANNOT BE ASSURED. THEREFORE, AS A MATTER OF POLICY ASP HAD DECIDED TO REPORT ALL INCIDENTS OF STERRAD CHEMICAL INDICATOR STRIPS NOT CHANGING COLOR CORRECTLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734389 STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL (FRC) FRC ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1