BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VALVE WITH INLINE RESERVOIR

    MDR report key: 3121778 · Received May 21, 2013

    Report

    Report Number
    1226348-2013-17399
    Event Type
    Injury
    Date Received
    May 21, 2013
    Date of Event
    April 23, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    CODMAN HAS REQUESTED RETURN OF THE VALVE FOR EVALUATION. HISTORICALLY, FOR COMPLAINTS OF THIS NATURE, EXAMINATIONS OF THE VALVES HAVE REVEALED THE ACCUMULATIONS OF BIOLOGICAL DEBRIS WITHIN THE VALVES OR CATHETERS, WHICH HAVE RESULTED IN BLOCKAGES WITHIN THE DEVICES, RESTRICTING FLOW. REVIEWS OF THE DEVICE HISTORY RECORDS HAVE CONFIRMED THAT THE VALVES HAVE MET SPECIFICATIONS WHEN RELEASED TO STOCK. A FOLLOW UP REPORT WILL BE FILED IF THE INVESTIGATION OF THIS DEVICE REVEALS A RESULT DIFFERENT FROM THAT WHICH IS STATED ABOVE OR IF ANY FURTHER INFORMATION REGARDING THE CAUSE OR MODE OF FAILURE IS MADE AVAILABLE. OTHERWISE, THE COMPLAINT IS CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PLEASE NOTE THAT THE DEVICE RETURNED WAS ACTUALLY THAT OF PRODUCT CODE 82-3142 AND NOT 82-3842 AS INITIALLY REPORTED. IT WAS NOTED THAT THIS COMPLAINT COULD NOT BE CONFIRMED. THE DEVICE WAS VISUALLY AND FUNCTIONALLY TESTED AND WAS FOUND TO WORK IN ACCORDANCE WITH THE MANUFACTURING SPECIFICATIONS. THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED IN THE LABORATORY SETTING. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTIONS. 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 AFTER IMPLANTATION, IT WAS NOTED THAT FLUID DID NOT FLOW THROUGH THE DEVICE. AS A RESULT, THE DEVICE WAS REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    224259 HAKIM VALVE WITH INLINE RESERVOIR SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. 1083486

    Patients

    Seq Age Sex Outcome Treatment
    1 9 YR Required Intervention