BEUDAMED
    FDA Adverse Event Summary report: N

    VERIFY V24 SELF CONTAINED BI

    MDR report key: 2241907 · Received September 9, 2011

    Report

    Report Number
    3004080920-2011-00007
    Date Received
    September 9, 2011
    Date of Event
    August 10, 2011
    Report Date
    September 9, 2011
    Manufacturer
    STERIS BIOLOGICAL OPERATIONS
    Product Code
    FRC
    PMA / PMN Number
    K083097
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    STERIS IMPLEMENTED A PRODUCTION PROCESS OF WASHING THE SCBI VIALS PRIOR TO INOCULATION, WHICH HAS PROVEN TO BE EFFECTIVE IN ENSURING THE PROPER PERFORMANCE OF THE VERIFY V24 SCBI AS EVIDENCED BY CUSTOMER COMPLAINTS.

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORTED THAT THE PROCESSING CYCLE FOR THE INSTRUMENTS USED IN THE PATIENT PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO ABNORMALITIES. THE CYCLE PRINTOUT CONFIRMED THAT THE CYCLE WAS COMPLETED SUCCESSFULLY AND ALL CRITICAL PARAMETERS WERE MET. A STERIS SERVICE TECHNICIAN INSPECTED THE V-PRO STERILIZER AND CONFIRMED THAT THE UNIT WAS OPERATING ACCORDING TO SPECIFICATIONS. IN ADDITION, THE FACILITY MONITORS ALL V-PRO CYCLES WITH CHEMICAL INDICATORS (CI); THE CI USED IN THE CYCLE WAS REPORTED TO HAVE PASSED. THE PASSING CI RESULT CONFIRMS THE RESULT OF THE PROCESSOR CYCLE PRINTOUT BY VERIFYING THAT THE LOAD WAS EXPOSED TO THE REQUIRED CONCENTRATION OF VAPORIZED HYDROGEN PEROXIDE. BASED ON THE RESULTS OF THE PROCESSOR RECORD AND CI AND INSPECTION OF THE V-PRO STERILIZER, IT IS CONCLUDED THAT THE INSTRUMENTS PROCESSED IN THE UNIT WERE PROPERLY STERILIZED. INVESTIGATION OF THIS EVENT IS IN PROCESS; A FOLLOW-UP REPORT WILL BE FILED WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    ON (B)(6), 2011 PINECONE IMPLEMENTED ADDITIONAL QA RELEASE TEST REQUIREMENTS, INCLUDING SIMULATED USE TESTING, ON EVERY LOT OF SCBIS PRIOR TO RELEASE. TO DATE, THIS ACTION APPEARS TO HAVE EFFECTIVELY RESOLVED THE ISSUE.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED THAT THEY RECEIVED A POSITIVE BIOLOGICAL INDICATOR (BI) RESULT FOR A LOAD RUN IN A V-PRO STERILIZER. THE INSTRUMENTS PRESENT IN THE CYCLE HAD BEEN USED IN A PATIENT PROCEDURE AND THE USER FACILITY MONITORED THE PATIENT PER THEIR HOSPITAL PROTOCOL. NO INJURIES HAVE BEEN REPORTED; REQUESTS FOR ADDITIONAL INFORMATION ON THE PATIENT STATUS HAVE NOT BEEN RESPONDED TO BY THE USER FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VERIFY V24 SELF CONTAINED BI BIOLOGICAL INDICATOR FRC STERIS BIOLOGICAL OPERATIONS 120201

    Patients

    Seq Age Sex Outcome Treatment
    1