BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR

    MDR report key: 2030083 · Received March 25, 2011

    Report

    Report Number
    2084725-2011-00025
    Event Type
    Malfunction
    Date Received
    March 25, 2011
    Date of Event
    February 28, 2011
    Report Date
    March 1, 2011
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FRC
    PMA / PMN Number
    K994055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY, TRENDING BY PRODUCT LINE, FAILURE MODE AND EFFECTS ANALYSIS, HEALTH HAZARD ANALYSIS AND SYSTEM HAZARD USE MISUSE ANALYSIS. THE DHR (DEVICE HISTORY RECORD) REVIEW REVEALED NO ISSUES THAT WOULD LEAD TO LEAKING OR DRIED VIAL. TRENDING ANALYSIS FOR "LEAKING"/"LEAKING-AFTER USE" WAS ANALYZED FOR THE PERIOD OF (B)(6) 2010 TO (B)(6) 2011; NO SIGNIFICANT TREND WAS OBSERVED. THE FMEA (FAILURE MODE AND EFFECTS ANALYSIS) DEMONSTRATES THAT THE RPN FOR THE FAILURE MODE OF "BROKEN AMPOULE OBSERVED AFTER STERRAD PROCESS" IS AT AN ACCEPTABLE LEVEL. THE HHA (HEALTH HAZARD ANALYSIS) WAS REVIEWED AND THE RISK FOR THIS ISSUE WAS ASSESSED AS NONE/NEGLIGIBLE. THE SHUMA (SYSTEM HAZARD USE MISUSE ANALYSIS) WAS REVIEWED FOR THIS ISSUE AND THE RISK WAS ASSESSED AS "BROADLY ACCEPTABLE". THE CUSTOMER COMPLAINT OF A LEAKING/DRIED CYCLESURE 24 BI FOLLOWING PROCESSING IN THE STERRAD SYSTEM COULD NOT BE CONFIRMED AND IS ATTRIBUTED TO "SHIPPING DAMAGE" AS WELL AS "FAILURE TO FOLLOW INSTRUCTIONS". AMPOULE INTEGRITY CAN BE COMPROMISED VIA ROUGH HANDLING, SHIPPING, ETC., THEREBY CAUSING MICROFRACTURES AND ULTIMATELY LEAKING AND/OR DRIED VIAL DURING STERRAD PROCESSING. TO MITIGATE POTENTIAL SHIPPING DAMAGE, THE IFU REQUIRES THE AMPOULE INTEGRITY TO BE CONFIRMED PRIOR TO BI USAGE; HOWEVER, THE CUSTOMER DID NOT CONFIRM THE AMPOULE INTEGRITY. THE CASE FOR SHIPPING DAMAGE IS FURTHER SUPPORTED BY RETAIN SAMPLE TESTING RESULTS WHICH DID NOT CONFIRM THE CUSTOMER'S COMPLAINT AS NO BROKEN, LEAKING AMPOULES AND/OR DRIED VIALS WERE OBSERVED PRIOR TO OR AFTER PROCESSING.

    Additional Manufacturer Narrative · 1

    THE USER IS NOT ALLEGING A POSITIVE BI RESULT, BUT RATHER MEDIA LEAKAGE. A BI WITH LOW MEDIA OR A LOW NUMBER OF SPORE CAN GIVE A FALSE POSITIVE PRESENTATION. A HHE (HEALTH HAZARD EVALUATION) FOR MEDIAL EVAPORATION AND LOW TITER (EQUIVALENT TO LOW SPORE) WAS PERFORMED AND THE ASSOCIATED RISK IS CONSIDERED LOW.

    Description of Event or Problem · 1

    A FACILITY REPORTED THAT WHEN REMOVING A LOAD FROM A COMPLETED STERRAD CYCLE, THERE WAS MEDIA LEAKAGE FROM THE STERRAD CYCLESURE 24 BIOLOGICAL INDICATOR. THE FACILITY STATED THAT THE INTEGRITY OF THE BI WAS NOT CHECKED BEFORE PROCESSING. IT IS NOT KNOWN AT THIS TIME IF THE FACILITY WAS ABLE TO READ THE BI. IT IS ALSO UNKNOWN IF THE LOAD WAS RECALLED AND REPROCESSED.

    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 277107

    Patients

    Seq Age Sex Outcome Treatment
    1