BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM VALVE

    MDR report key: 4791385 · Received May 22, 2015

    Report

    Report Number
    1226348-2015-10292
    Event Type
    Malfunction
    Date Received
    May 22, 2015
    Date of Event
    April 24, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 160MMH2O. THE VALVE WAS VISUALLY INSPECTED: NO DEFECTS WERE NOTED. THE VALVE WAS IRRIGATED WITH PURIFIED WATER, NO OCCLUSION WAS NOTED. THE CATHETER WERE IRRIGATED WITH PURIFIED WATER, NO OCCLUSION WAS NOTED. THE SIPHONGUARD WAS IRRIGATED, NO PROBLEM WAS NOTED. THE VALVE WAS LEAK TESTED, NO LEAKAGE WAS NOTED. THE VALVE WAS TESTED FOR PROGRAMMING. THE VALVE PASSED THE TEST. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE NS9008 WITH LOT CTBCC0, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 19TH FEBRUARY 2015. NO ROOT CAUSE COULD BE DETERMINED AS THE VALVE FUNCTIONED. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    ON (B)(6) 2015, L-P SHUNT IMPLANTATION WAS CONDUCTED. SINCE FLUID DID NOT FLOW THROUGH THE VALVE, THE SURGEON IMPLANTED A BACKUP DEVICE INSTEAD. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    334329 HAKIM VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CTBCC0

    Patients

    Seq Age Sex Outcome Treatment
    1