BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR

    MDR report key: 5524896 · Received March 24, 2016

    Report

    Report Number
    2084725-2016-00162
    Event Type
    Malfunction
    Date Received
    March 24, 2016
    Date of Event
    February 26, 2016
    Report Date
    February 26, 2016
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FRC
    PMA / PMN Number
    K994055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    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' LOT NUMBER - THE CORRECT LOT NUMBER IS 2781511-06 .

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE BATCH HISTORY, TRENDING OF LOT NUMBER, PRODUCT RETURN AND SYSTEM RISK ANALYSIS (SRA). THE BATCH HISTORY WAS REVIEWED AND THE INVOLVED LOT MET MANUFACTURER SPECIFICATIONS AT THE TIME OF RELEASE. TRENDING ANALYSIS BY LOT NUMBER WAS REVIEWED FROM 08/30/2015 TO 02/26/2016 AND TRENDING WAS NOT EXCEEDED. THE SRA INDICATES THE RISK ASSOCIATED WITH HAZARD OF 'QUALITY PROBLEM WITH NO IMPACT ON SAFETY IS "LOW." FUNCTIONALITY TESTING WAS PERFORMED ON THIRTY CI STRIPS FROM UNUSED CUSTOMER RETURNED RMA. ALL THIRTY CI STRIPS MET SPECIFICATION. THE SUPPLIER WAS SENT UNUSED CUSTOMER SAMPLES FOR INSPECTION. THE SUPPLIER FOUND THE PRODUCT TO BE WITHIN SPECIFICATION. IT IS UNLIKELY THAT THE CI STRIP ISSUE WAS CAUSED BY A PERFORMANCE ISSUE OF THE PRODUCT SINCE THE UNUSED RMA MET FUNCTIONAL SPECIFICATION, BATCH REVIEW FOUND NO ANOMALIES THAT WOULD CONTRIBUTE TO THE COMPLAINT ISSUE, AND THE LOT TRENDING ANALYSIS RESULT WAS TRENDING NOT EXCEEDED. ADDITIONALLY, NO MANUFACTURING ANOMALIES WERE OBSERVED IN THE UNUSED RETURNED CI STRIPS. AN ISSUE WITH STERRAD® PERFORMANCE CANNOT BE DETERMINED SINCE THE CUSTOMER WAS UNRESPONSIVE TO MULTIPLE ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION. AS SUCH THERE IS INSUFFICIENT INFORMATION FOR INVESTIGATION. THE CUSTOMER LETTER WAS SENT TO PROVIDE INFORMATION ON INTERPRETING POST PROCESSING COLOR OF STERRAD CHEMICAL INDICATORS. THE ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED THEY WERE "NOT SURE THAT STERILIZATION IS DONE" WHILE USING A STERRAD CHEMICAL INDICATOR STRIP. IT IS UNKNOWN IF THE AFFECTED LOAD WAS RECALLED OR RELEASED FOR USE. 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. ASP WILL CONTINUE TO FOLLOW UP FOR ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    179430 STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL (FRC) FRC ADVANCED STERILIZATION PRODUCTS NA

    Patients

    Seq Age Sex Outcome Treatment
    1