BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLEX ADV.3000ML GEL-VAC

    MDR report key: 3191349 · Received June 26, 2013

    Report

    Report Number
    1423537-2013-00026
    Event Type
    Malfunction
    Date Received
    June 26, 2013
    Date of Event
    June 6, 2013
    Report Date
    June 26, 2013
    Manufacturer
    CARDINAL HEALTH
    Product Code
    GCX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FIVE SAMPLES WERE RECEIVED AND A DETAILED INVESTIGATION ON THE REPORTED CONCERN WAS CONDUCTED. A REVIEW OF THE MANUFACTURING DEVICE HISTORY RECORD FOR THE REFERENCED LOT NUMBER WAS COMPLETED. NO NON-CONFORMANCE WITH REGARD TO ¿SUCTION FAILURE¿ WAS DOCUMENTED DURING THE MANUFACTURING OF THIS BATCH OR IS PRESENT IN CURRENT PRODUCTION. THE INVESTIGATION DETERMINED THAT ALL PRODUCTS WERE MANUFACTURED, INSPECTED AND RELEASED IN ACCORDANCE TO OUR ESTABLISHED SPECIFICATION FOR QUALITY AND EFFICACY. A DETAILED INVESTIGATION WAS CONDUCTED ON ALL SAMPLES RECEIVED AND LINERS WERE SUBJECTED TO A VISUAL INSPECTION, SUCTION TEST AND HIGH VACUUM FLOW RATE EQUIPMENT TEST. THE VISUAL INSPECTION REVEALED NO DEFECTS AND THE HIGH-FLOW EQUIPMENT TEST (PER (B)(4)) REVEALED ALL OF THE SAMPLES MET THE TEST CRITERIA. LIKEWISE, A SUCTION TEST AT 700MMHG WAS PERFORMED ON ALL LINERS AND ALL FUNCTIONED AS DESIGNED. PLEASE NOTE THAT A DECREASE IN THE AIR FLOW OF THE LINERS WERE NOTED DURING TESTING BUT AS PER (B)(4), SUCTION EQUIPMENT SHALL DEVELOP A VACUUM OF AT LEAST 60KPA BELOW ATMOSPHERIC PRESSURE WITHIN 10 SECONDS AND ALL LINERS RECEIVED MET THE TEST CRITERIA. BASED ON THE FACT THAT SAMPLES RECEIVED FUNCTIONED AS DESIGNED, A ROOT CAUSE CANNOT BE IDENTIFIED AND CORRECTIVE AND PREVENTIVE ACTION CANNOT BE INITIATED. WE WILL CONTINUE TO MONITOR TRENDS AND UTILIZE THE INFORMATION AS PART OF CONTINUOUS IMPROVEMENT.

    Description of Event or Problem · 1

    ALMOST COMPLETE LOSS OF VACUUM DURING A PROSTATE REMOVAL PROCEDURE. AS A RESULT, HEMOSTASIS WAS NOT POSSIBLE DURING ABUNDANT BLEEDING. USE OF ELECTRIC VACUUM SYSTEM AND ANESTHETIST VACUUM SYSTEM WERE USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289934 FLEX ADV.3000ML GEL-VAC SUCTION LINER GCX CARDINAL HEALTH 65651930PG 13D10

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other