BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR

    MDR report key: 5490724 · Received March 9, 2016

    Report

    Report Number
    2084725-2016-00137
    Event Type
    Malfunction
    Date Received
    March 9, 2016
    Date of Event
    October 21, 2015
    Report Date
    October 23, 2015
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FRC
    PMA / PMN Number
    K994055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: ACTUAL DEVICE NOT EVALUATED. RESULT: NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR), TRENDING OF THE PRODUCT MALFUNCTION CODE, TRENDING OF LOT NUMBER, SYSTEM RISK ANALYSIS (SRA), PRODUCT RETURN AND RETAINS ANALYSIS. THE DHR WAS REVIEWED AND THE INVOLVED LOT MET MANUFACTURER SPECIFICATIONS AT THE TIME OF RELEASE. NO ANOMALIES WERE OBSERVED THAT WOULD CONTRIBUTE TO THE CUSTOMER'S EXPERIENCED ISSUE. TRENDING ANALYSIS FOR THE PRODUCT CODE OF 'SUSPECTED POSITIVE BI" WAS REVIEWED FROM AUGUST 2014 THROUGH FEBRUARY 2015 AND REVEALED A SIGNIFICANT TREND WHICH WAS ADDRESSED THROUGH CAPA. TRENDING ANALYSIS BY LOT NUMBER WAS REVIEWED FROM 08/18/2015 TO 03/03/2016 AND REVEALED TRENDING EXCEEDED AND IS BEING ADDRESSED THROUGH CAPA. THE PRODUCT WAS NOT RETURNED FOR FUNCTIONAL ANALYSIS. IT WAS DISCARDED BY THE CUSTOMER. THE SRA INDICATES THE RISK ASSOCIATED WITH A QUALITY PROBLEM WITH NO IMPACT TO SAFETY IS "LOW." THIRTY-TWO RETAINS BIS WERE SUBJECT TO FUNCTIONAL EVALUATION. ALL THIRTY-TWO BIS MET SPECIFICATION. IT IS UNLIKELY THE SUSPECTED POSITIVE BI WAS CAUSED BY A MANUFACTURING ISSUE AS THE RETAINS MET FUNCTIONAL SPECIFICATION AND DHR REVIEW FOUND NO ANOMALIES THAT WOULD CONTRIBUTE TO A POSITIVE BI RESULT. REQUESTS FOR ADDITIONAL INFORMATION WITH THE CUSTOMER WAS UNSUCCESSFUL. THE ISSUE WILL CONTINUE TO BE TRACKED AND TRENDED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A POSITIVE RESULT WITH A CYCLESURE® 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED STERRAD® 100NX EXPRESS CYCLE VALIDATION. THERE WAS NO LOAD AFFECTED. 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 POSITIVE CYCLESURE® 24 BIOLOGICAL INDICATORS. (B)(4) ARE RELATED COMPLAINTS FROM THE SAME FACILITY. THIS IS TWO OF FOUR 3500A REPORTS BEING SUBMITTED FOR THIS PRODUCT MALFUNCTION. PLEASE REFERENCE MANUFACTURER REPORT NUMBERS: 2084725-2016-00136, 2084725-2016-00137, 2084725-2016-00138 AND 2084725-2016-00139.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    146694 STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL (FRC) FRC ADVANCED STERILIZATION PRODUCTS NA 23015266

    Patients

    Seq Age Sex Outcome Treatment
    1