BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR

    MDR report key: 2071184 · Received April 27, 2011

    Report

    Report Number
    2084725-2011-00029
    Event Type
    Malfunction
    Date Received
    April 27, 2011
    Date of Event
    March 29, 2011
    Report Date
    March 29, 2011
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FRC
    PMA / PMN Number
    K994055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SUSPECT POSITIVE RESULT. PRODUCT SAMPLE HAS BEEN RECEIVED AT ASP. THE INVESTIGATION RESULTS WILL BE REPORTED ON A FOLLOW UP REPORT.

    Additional Manufacturer Narrative · 1

    THE DATE-OF-MANUFACTURE FOR THIS LOT IS 01/26/2011. EXPIRY DATE: 2012 - 05. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY, TRENDING BY PRODUCT LINE AND LOT NUMBER, FAILURE MODE AND EFFECTS ANALYSIS AND THE HEALTH HAZARD ANALYSIS. THE DHR (DEVICE HISTORY RECORD) REVIEW DID NOT REVEAL ANY ISSUES THAT WOULD LEAD TO POSITIVE BI. TRENDING ANALYSIS FOR THE PRODUCT CODE OF 'SUSPECTED POSITIVE BI' DEMONSTRATES THERE WAS NO SIGNIFICANT TREND. TRENDING ANALYSIS BY LOT NUMBER REVEALED THERE WAS ONE OTHER SIMILAR INCIDENT AT THE SAME FACILITY. THE FMEA (FAILURE MODE AND EFFECTS ANALYSIS) REVEALS THAT THE RPN FOR THIS ISSUE IS AT AN ACCEPTABLE LEVEL. THE HHA (HEALTH HAZARD ANALYSIS) WAS REVIEWED FOR THIS ISSUE AND THE RISK INDEX IS CONSIDERED NONE/NEGLIGIBLE. THE CUSTOMER COMPLAINT OF A SUSPECTED POSITIVE BI WAS CONFIRMED AND IS ATTRIBUTED TO THE LOAD. THE CUSTOMER PROCESSED TWO STRYKER 4200 DRILLS IN A KMILLER SILVER CONTAINER, NEITHER OF WHICH IS APPROVED FOR STERILIZATION IN THE STERRAD NX SYSTEM. THE CUSTOMER DID NOT FOLLOW THE INSTRUCTIONS PROVIDED IN THE STERRAD NX USER'S GUIDE OR THE CYCLESURE IFU. FUNCTIONAL ANALYSIS TESTING PERFORMED ON THE RETURNED AND RETAIN SAMPLES INDICATE THAT THE PRODUCT FUNCTIONS AS INTENDED.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SUSPECT POSITIVE STERRAD® CYCLESURE 24 BIOLOGICAL INDICATOR (BI) AFTER A COMPLETED CYCLE IN THEIR STERRAD NX STERILIZER. THE LOAD WAS NOT RECALLED SUCCESSFULLY. THERE ARE NO REPORTS OF INJURY OR HARM FROM THE EVENT. THE NURSE IN CHARGE AS WELL AS THE DOCTOR WERE NOTIFIED. THE LOAD CONTENTS CONTAINED TWO STRYKER 4200 DRILLS. THE STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR (BI) WAS PLACED ON THE BOTTOM RACK, IN THE BACK OF THE LOAD IN A TYVEK POUCH. THE RESULT FOR THE PREVIOUS BI WAS NEGATIVE AS WAS THE SUBSEQUENT BI. AT THIS TIME, NO ADDITIONAL INFORMATION IS AVAILABLE REGARDING THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL (FRC) FRC ADVANCED STERILIZATION PRODUCTS NA 026117

    Patients

    Seq Age Sex Outcome Treatment
    1