BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM PROGRAMMABLE VALVE MICRO W/RICKHAM

    MDR report key: 5720493 · Received June 13, 2016

    Report

    Report Number
    1226348-2016-10424
    Event Type
    Malfunction
    Date Received
    June 13, 2016
    Date of Event
    May 19, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    PK980778
    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, IT WAS NOTED THAT THE IMAGES WERE TAKEN OF THE ¿AS RECEIVED¿ VALVE. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 30MMH2O. THE VALVE WAS HYDRATED FOR ABOUT 25 HOURS. THE VALVE WAS VISUALLY INSPECTED: NO DEFECTS WERE NOTED. THE CATHETER WAS VISUALLY INSPECTED AND A CUT WAS NOTED. THE VALVE WAS FLUSHED, THE VALVE PASSED THE TEST NO OCCLUSION WAS NOTED. THE VALVE WAS LEAK TESTED, NO LEAKS WERE NOTED. THE CATHETERS WERE IRRIGATED WITH PURIFIED WATER, NO OCCLUSION WAS NOTED, BUT LEAKED FROM THE CUT IN THE CATHETER. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3113, WITH LOT CTPBCW, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN 15TH JANUARY 2016. THE ROOT CAUSE TO THE CUT IN THE CATHETER IS PROBABLY DUE TO A SHARP OBJECT COMING INTO CONTACT WITH THE CATHETER. AS NOTED IN THE IFU SILICONE HAS A LOW CUT / TEAR RESISTANCE. NO LEAKAGE WAS FOUND WITH THE VALVE. 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.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    IT IS SAID THAT THERE IS A HOLE ON THE SILICONE HOUSING OF THE SHUNT DEVICE, AND AS A RESULT, THERE WAS LEAKAGE OF SALINE WHEN THE SURGEON FILLED IT WITH SALINE BEFORE IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    374584 HAKIM PROGRAMMABLE VALVE MICRO W/RICKHAM SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CTPBCW

    Patients

    Seq Age Sex Outcome Treatment
    1