BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VALVE

    MDR report key: 3150600 · Received June 6, 2013

    Report

    Report Number
    1226348-2013-18329
    Event Type
    Injury
    Date Received
    June 6, 2013
    Date of Event
    May 22, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 PROXIMAL CONNECTOR WAS MISSING. IT WAS ALSO NOTED THAT THE CATHETER WAS CLEAN CUT AT THE DISTAL END OF THE VALVE. THE DEVICE WAS TESTED AND AN OCCLUSION WAS FOUND AT THE INLET OF THE RUBY BALL. ONCE THE BALL WAS POPPED FREE AND IRRIGATED THE FLOW WAS NORMAL. THE DEVICE ALSO FAILED THE PROGRAMMING TEST. SINCE THE VENTRICULAR CATHETER WAS MISSING IT WAS NOT POSSIBLE TO CONDUCT THE PRESSURE TEST. BIOLOGICAL DEBRIS WAS SEEN THROUGHOUT THE DEVICE, WHICH MAY HAVE CONTRIBUTED TO THE PROBLEM REPORTED BY THE CUSTOMER. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION. 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

    THE AFFILIATE REPORTED THAT THE LUMBER CATHETER BROKE. THE DEVICE WAS REVISED DUE TO THE VALVE MALFUNCTION AND CATHETER BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249903 HAKIM VALVE SHUN, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CJDCYV

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention