BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CYCLESURE BIOLOGICAL INDICATOR

    MDR report key: 1825594 · Received September 3, 2010

    Report

    Report Number
    2084725-2010-00267
    Event Type
    Malfunction
    Date Received
    September 3, 2010
    Date of Event
    August 5, 2010
    Report Date
    August 5, 2010
    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

    CORRECTION: EXPIRATION DATE: 07/31/2011. CORRECTION: MANUFACTURE DATE: 3/24/2010. ASP INVESTIGATION SUMMARY: THE INVESTIGATION INCLUDED A REVIEW OF THE DEVICE HISTORY, TRENDING BY PRODUCT LINE AND SYSTEM SERIAL NUMBER, FAILURE MODE AND EFFECTS ANALYSIS AND THE HEALTH HAZARD EVALUATION. THE DHR (DEVICE HISTORY RECORD) FOR LOT# 061101 WAS REVIEWED. THERE WAS NO NON-CONFORMANCE REPORT FOUND. THE COMPLAINT HISTORY FOR THE CYCLESURE BI, LOT# 061101 WAS REVIEWED. THERE WAS ONE OTHER SIMILAR COMPLAINT REPORTED FOR DRIED VIAL. TRENDING ANALYSIS FOR DRIED VIAL ISSUES ASSOCIATED TO THE CYCLESURE INDICATES SPIKES IN THE TREND THAT WAS INVESTIGATED IN A FAILURE INVESTIGATION REPORT (FIR). THE FMEA (FAILURE MODE AND EFFECTS ANALYSIS) ASSESSMENT REVEALED A LOW-SAFETY RISK. THE HHE (HEALTH HAZARD EVALUATION) WAS REVIEWED AND THE ISSUE IS CONSIDERED TO BE NONE/NEGLIGIBLE RISK. THE COMPLAINT COULD NOT BE CONFIRMED. BASED ON THE INFORMATION AVAILABLE, THERE WAS NO PROBLEM FOUND WITH THE SAMPLE RETURNED FOR INVESTIGATION OR THE RETAIN SAMPLES. THE RISK ASSOCIATED WITH THE FAILURE MODE IS LOW. THERE WERE NO OTHER SIMILAR COMPLAINTS REPORTED FOR DRIED VIAL. IT IS RECOMMENDED THAT THE CUSTOMER FOLLOW THE CYCLESURE BI IFU TO CHECK THE INTEGRITY OF THE BI PRIOR TO USE.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: IMPLANT - PART AND SERIAL NUMBERS UNKNOWN. STERRAD - SERIAL NUMBER UNKNOWN. (B)(4): DRIED MEDIA. THE STERRAD USER GUIDE STATES IN THE LIST OF ITEMS NOT TO BE PROCESSED IN THE STERRAD: SOME IMPLANTS FOR WHICH THE MANUFACTURER HAS NOT SPECIFICALLY RECOMMENDED FOR STERILIZATION IN THE STERRAD STERILIZER

    Description of Event or Problem · 1

    THE CUSTOMER INDICATED THERE WERE NO CRACKS NOTICED ON THE CYCLESURE BIOLOGICAL INDICATOR (BI) PRIOR TO PROCESSING. HOWEVER, THERE WERE ONLY 2-3 DROPS OF MEDIA LEFT IN THE AMPOULE AFTER PROCESSING. IT IS UNKNOWN WHERE IN THE CHAMBER THE BI WAS PLACED. THE LOAD INCLUDED AN IMPLANT WHICH IS USUALLY PROCESSED IN AN AUTOCLAVE. THE CUSTOMER HAD AN URGENT OPERATION AND TOOK ADVANTAGE OF THE STERRAD STERILIZATION SYSTEM DUE TO LESS AMOUNT OF PROCESSING TIME REQUIRED COMPARED TO THE AUTOCLAVE. THE LOAD WAS NOT RECALLED AND NO HARM OR INJURY WAS REPORTED. AN ASP SALES REPRESENTATIVE EXPLAINED TO THE CUSTOMER HOW TO HANDLE BIS, STERILIZE IMPLANTS, AND THE REQUIREMENTS FOR BI STORAGE ENVIRONMENT.

    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