BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERRAD® CYCLESURE® 24 BIOLOGICAL INDICATOR

    MDR report key: 2615333 · Received June 13, 2012

    Report

    Report Number
    2084725-2012-00027
    Event Type
    Malfunction
    Date Received
    June 13, 2012
    Date of Event
    May 29, 2012
    Report Date
    May 29, 2012
    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

    (B)(4): SUSPECT POSITIVE BI.

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY RECORD, TRENDING BY PRODUCT LINE AND LOT NUMBER, FAILURE MODE AND EFFECTS ANALYSIS AND HEALTH HAZARD ANALYSIS. THE DHR (DEVICE HISTORY RECORD) WAS REVIEWED AND DEMONSTRATED NO ANOMALIES THAT WOULD CONTRIBUTE TO THIS ISSUE. TRENDING ANALYSIS FOR THE PRODUCT CODE OF 'SUSPECTED POSITIVE BI' WAS REVIEWED FOR A TIMEFRAME OF (B)(4) 2011 TO (B)(4) 2012. (B)(4). THE ISSUE WILL CONTINUE TO BE MONITORED. TRENDING ANALYSIS BY LOT NUMBER WAS PERFORMED. THE LOT HISTORY FROM (B)(4) 2012 TO (B)(4) 2012 FOUND THAT NO SIMILAR INCIDENTS WERE REPORTED. THE FMEA (FAILURE MODE AND EFFECTS ANALYSIS) REVEALS THAT THE RISK FOR THIS ISSUE IS AT AN ACCEPTABLE LEVEL. THE HHA (HEALTH HAZARD ANALYSIS) WAS REVIEWED AND THE ISSUE IS CONSIDERED TO HAVE A RISK OF "NONE/NEGLIGIBLE". (B)(4) RETAINS SAMPLES WERE TESTED AND MET FUNCTIONAL REQUIREMENTS AFTER INCUBATION. VISUAL INSPECTION OF THE RETURNED PRODUCT FOUND THE CI DISC IS A GOLDEN COLOR, INDICATIVE OF PEROXIDE EXPOSURE. THERE IS A STICKY RESIDUE ON TOP OF THE CI DISC. IT CANNOT BE DETERMINED IF THIS RESIDUE OCCURRED DURING PROCESSING OR AFTER SHIPMENT FROM MEDIA LEAKAGE SINCE THE CAP OF THE BI HAD BEEN REMOVED BY THE CUSTOMER AND LOOSELY PLACED BACK ONTO THE BI, ULTIMATELY SCRUNCHING THE LINER. IF THE LINER WAS WADDED IN SUCH A MANNER DURING INCUBATION, BOTH MEDIA EVAPORATION AND POTENTIAL CONTAMINATION COULD HAVE OCCURRED. NO MEDIA IS REMAINING, AND INTERNAL COMPONENTS ARE STAINED PURPLE. THERE ARE A SINGLE (B)(4) LINER AND SINGLE SPORE DISC PRESENT. THERE ARE NO PUNCTURES ON THE OUTER VIAL OR (B)(4) LINER THAT WOULD BE CONSISTENT WITH FALSE POSITIVE FROM EXTERNAL CONTAMINATION. INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE THE CAUSE OF THE ALLEGED SUSPECTED POSITIVE BI. DEVICE COMPATIBILITY CANNOT BE ELIMINATED AS A CONTRIBUTING FACTOR SINCE INFORMATION WAS UNAVAILABLE REGARDING THE SPECIFIC MAKES/MODELS OF DEVICES WITHIN THE LOAD. ADDITIONALLY, THE RETURNED SUSPECT BI HAD BEEN DISASSEMBLED AT SOME POINT; THEREFORE, FINDINGS FROM THE VISUAL ANALYSIS COULD BE CONSIDERED COMPROMISED. THE CUSTOMER SUSPECTED THAT THE BI WAS DAMAGED SINCE THE "TACTILE FEELING" FROM HANDLING IT WAS NOT USUAL. STERRAD MALFUNCTION WAS RULED OUT AS A CONTRIBUTING FACTOR. THE CYCLE PASSED, THE CI CHANGED APPROPRIATELY, AND THE PREVIOUS/SUBSEQUENT BIS WERE NEGATIVE FOR GROWTH. CYCLESURE MALFUNCTION WAS ALSO ELIMINATED AS A CONTRIBUTING FACTOR SINCE THE RETAINS EVALUATION DEMONSTRATED THAT THE PRODUCT FUNCTIONS AS INTENDED WHEN USED PER IFU, DHR REVIEW REVEALED NO ANOMALIES THAT WOULD CONTRIBUTE TO THIS ISSUE, AND LOT HISTORY REVIEW DEMONSTRATED NO TREND WITHIN THIS LOT.

    Additional Manufacturer Narrative · 1

    SEX:CORRECTED FROM FEMALE TO UNKNOWN.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED A SUSPECTED POSITIVE BI FROM A COMPLETED STERRAD NX STERILIZER CYCLE. THE CUSTOMER CONSIDERED THAT THERE WAS A PROBLEM IN THE BI AMPOULE ONLY AND DID NOT RECALL THE LOAD. THERE WAS NO DEFECT DETECTED IN EITHER THE CI (CHEMICAL INDICATOR) OR THE STERRAD NX STERILIZER. THE RESULTS OF THE PREVIOUS AND SUBSEQUENT BI WERE NEGATIVE. THE CUSTOMER ALSO REPORTED A DECREASE IN THE AMOUNT OF THE MEDIA AFTER 24 HOURS OF INCUBATION WITH THE CYCLESURE 24 BIOLOGICAL INDICATOR (BI). THE MEDIA SEEMED TO FLOW OUT AND EXTENDED TO THE TYVEK WHEN VIEWED THROUGH THE CAP HOLE. THE CUSTOMER FELT SOMETHING WAS WRONG WHEN HE CRUSHED THE VIAL. THERE WAS NO TACTILE FEELING CAUSING THE SUSPICION THAT THE VIAL MIGHT HAVE BEEN DAMAGED BEFORE. THERE ARE NO REPORTS OF INJURY OR HARM FROM THE EVENT. NO PATIENTS WERE GIVEN ANY ADDITIONAL ANTIBIOTICS OR TREATMENT/TEST DUE TO THE EVENT. 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 054127

    Patients

    Seq Age Sex Outcome Treatment
    1