BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYCLESURE BIOLOGICAL INDICATOR

    MDR report key: 1811343 · Received August 23, 2010

    Report

    Report Number
    2084725-2010-00263
    Event Type
    Malfunction
    Date Received
    August 23, 2010
    Date of Event
    July 26, 2010
    Report Date
    July 26, 2010
    Manufacturer
    ADVANCED STERILIZATION PRODUCTS
    Product Code
    FRC
    PMA / PMN Number
    K994055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY, THE COMPLAINT HISTORY, TRENDING BY PRODUCT LINE AND SYSTEM SERIAL NUMBER, FAILURE MODE AND EFFECTS ANALYSIS AND THE HEALTH HAZARD ANALYSIS. THE DHR (DEVICE HISTORY REVIEW) FOR THE CYCLESURE BIOLOGICAL INDICATOR (BI) WAS PERFORMED AND FOUND TO MEET ALL REQUIRED SPECIFICATIONS WITHOUT ANY MANUFACTURING NONCONFORMITIES AT THE TIME OR RELEASE FOR SHIPMENT. THE COMPLAINT HISTORY FOR THIS CYCLESURE BI LOT SHOWS NO OTHER SIMILAR COMPLAINTS. TRENDING ANALYSIS FOR NO GROWTH OF THE BI CONTROL ISSUES ASSOCIATED TO THE CYCLESURE DID NOT INDICATE A SIGNIFICANT TREND. (B)(4). ONE PROCESSED AND TWO UNPROCESSED CYCLESURE BI LOT 061101 WERE RETURNED FOR INVESTIGATION. VISUAL ANALYSIS OF THE TWO UNPROCESSED CYCLESURE BI INDICATED THAT THE VIALS WERE CRUSHED. THE CHEMICAL INDICATOR (CI) CAP COLOR WAS RED AND THE CAP WAS DEPRESSED. A SINGLE TYVEK LINER AND SPORE DISC WERE PRESENT IN EACH VIAL. THERE WAS NO REMAINING MEDIA IN THE VIALS. THERE WERE NO ANOMALIES FOUND WITH THE PROCESSED VIAL. A CONCLUSIVE ROOT CAUSE IS NOT CONFIRMED AS THOROUGH INVESTIGATION AND TESTING COULD NOT REPRODUCE THE REPORTED ISSUE OF A NO GROWTH OF THE CYCLESURE BI CONTROL. THE SAMPLES RETURNED FOR INVESTIGATION EXHIBITED GROWTH AFTER 24 HOURS OF INCUBATION. THE CUSTOMER WAS ADVISED TO REFER TO THE CYCLESURE BI IFU FOR PROPER BI USE REGARDING INCUBATION TEMPERATURE AND CHECKING FOR INTEGRITY PRIOR TO USE.

    Additional Manufacturer Narrative · 1

    (B)(4): NO GROWTH OF BI CONTROL

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED NO GROWTH OF A POSITIVE CONTROL FOR CYCLESURE BIOLOGICAL INDICATOR (BI). THE CONTROL DID NOT CHANGE COLOR CORRECTLY 24 HOURS AFTER INCUBATION. HOWEVER, IT CHANGED TO A PALE PURPLE AFTER 36 HOURS. THE CUSTOMER TRIED ANOTHER BI VIAL AS A POSITIVE CONTROL AND IT TURNED YELLOW AFTER 24 HOURS. THE CUSTOMER MENTIONED THAT THEY DO FOLLOW THE RECOMMENDED ASP PRODUCT IFU FOR HANDLING BIOLOGICAL INDICATORS. THE BI WAS CRUSHED BEFORE PROCESSING. THE CUSTOMER DID NOT REPORT ANY HUMAN REACTIONS DUE TO THIS EVENT. THIS IS ALL THE INFORMATION CURRENTLY AVAILABLE REGARDING THIS EVENT. FOLLOW-UP FOR ADDITIONAL INFORMATION AND CLARIFICATION WAS REQUESTED FROM THE INTERNATIONAL AFFILIATE. SHOULD ADDITIONAL INFORMATION BE RECEIVED, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CYCLESURE BIOLOGICAL INDICATOR INDICATOR, BIOLOGICAL (FRC) FRC ADVANCED STERILIZATION PRODUCTS NA 061101

    Patients

    Seq Age Sex Outcome Treatment
    1