BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM INLINE PROGRAMMABLE VALVE SG

    MDR report key: 6253349 · Received January 16, 2017

    Report

    Report Number
    1226348-2017-10048
    Event Type
    Malfunction
    Date Received
    January 16, 2017
    Date of Event
    December 28, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K992173
    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 VALVE WAS VISUALLY INSPECTED: NO DEFECTS WERE NOTED. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 120MMH2O. THE VALVE WAS HYDRATED FOR 24 HOURS. THE VALVE WAS TESTED FOR PROGRAMMING WITH PROGRAMMER 82-3126 WITH SERIAL NUMBER (B)(4), THE VALVE PASSED THE TEST. THE VALVE WAS FLUSHED, THE VALVE PASSED THE TEST NO OCCLUSION WAS NOTED. THE VALVE WAS LEAK TESTED, NO LEAKS WERE NOTED. THE VALVE WAS REFLUX TESTED, THE VALVE PASSED THE TEST. THE SIPHON GUARD WAS TESTED, THE VALVE PASSED THE TEST. THE VALVE WAS DRIED. THE SIPHON GUARD WAS REMOVED. THE VALVE WAS THEN PRESSURE TESTED, THE VALVE PASSED THE TEST. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 823162, WITH LOT CVDBNB, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 14TH APRIL 2016. NO ROOT CAUSE COULD BE DETERMINED, AS THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. 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

    THE DEVICE HAS BEEN RETURNED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    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 WAS REPORTED THAT NEAR THE END OF A VP SHUNT CASE, THE VALVE WAS FOUND TO BE LEAKING FROM THE BACK SIDE OF THE RESERVOIR. WHEN THE SURGEON PRIMED THE VALVE FROM THE PROXIMAL END SALINE CAME SHOOTING OUT OF THE BACK OF THE RESERVOIR. THE VALVE WAS REPLACED AND THE SURGERY WAS COMPLETED. THERE WAS NO REPORTED PATIENT HARM

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36441 HAKIM INLINE PROGRAMMABLE VALVE SG SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CVDBNB

    Patients

    Seq Age Sex Outcome Treatment
    1