BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VALVE, RIGHT ANGLE RES. UNITIZED SG

    MDR report key: 3892252 · Received June 24, 2014

    Report

    Report Number
    1226348-2014-11743
    Event Type
    Injury
    Date Received
    June 24, 2014
    Date of Event
    May 29, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE VALVE WAS RETURNED FOR EVALUATION. THE INVESTIGATION OF THE RETURNED VALVE DID CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER. THE LOT NUMBER WAS CPHB00, SERIAL NUMBER (B)(4), PRODUCT CODE 82-3146. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 100MMH2O. THE VALVE WAS VISUALLY INSPECTED, NEEDLE HOLES IN THE NEEDLE CHAMBER WERE NOTED, NO DEFECTS WERE NOTED. THE VALVE WAS IRRIGATED WITH PURIFIED WATER; AN OCCLUSION WAS NOTED AT THE INLET OF THE RUBY BALL. THEREFORE A FINE NEEDLE WAS INSERTED INTO THE FLOW OPENING OF THE VALVE INLET UNDER THE RUBY BALL AND ITS SEAT, THE RUBY BALL WAS MANUALLY POPPED FREE FROM ITS STUCK POSITION USING LIGHT FORCE. THE VALVE WAS IRRIGATED AGAIN, NO OCCLUSION WAS NOTED. THE SIPHON GUARD WAS IRRIGATED WITH PURIFIED WATER, NO OCCLUSION WAS NOTED. THE CATHETER WAS IRRIGATED WITH PURIFIED WATER, NO OCCLUSIONS WERE NOTED. THE VALVE WAS DRIED. THE VALVE WAS LEAK TESTED; THE VALVE ONLY LEAKED FROM THE NEEDLE HOLES . THE VALVE WAS REFLUX TESTED, THE VALVE PASSED THE TEST. THE VALVE WAS TESTED FOR PROGRAMMING; THE VALVE PASSED THE TEST. THE VALVE WAS THEN PRESSURE TESTED, THE VALVE PASSED THE TEST. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS FOUND ON THE SPRING, ON THE SPRING PILLAR, ON THE RUBY BALL, ON THE SEAT OF THE RUBY BALL, AND ON THE BASE PLATE. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE, PRODUCT CODE 82-3146, WITH LOT NUMBER CPHB00, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE (B)(6) 2013. THE ROOT CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER IS DUE TO BIOLOGICAL DEBRIS FOUND ON THE SPRING, ON THE SPRING PILLAR, ON THE RUBY BALL, ON THE SEAT OF THE RUBY BALL, AND ON THE BASE PLATE. NO CORRECTIVE ACTION IS NEEDED BASED ON THE RESULTS OF THE EVALUATION.

    Description of Event or Problem · 1

    E-MAIL RECEIVED FROM THE SALES REP. INFORMED THAT: "CUSTOMER REPORTED THAT VALVE FAILED. IT WAS REPLACED. NO OTHER DETAILS AVAILABLE. PLEASE SEND A WARRANTY REPLACEMENT TO THE CUSTOMER".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    368994 HAKIM VALVE, RIGHT ANGLE RES. UNITIZED SG SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF CPHBOO

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Required Intervention