BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROGRAMMABLE VALVE, RT ANGLE

    MDR report key: 3954812 · Received July 24, 2014

    Report

    Report Number
    1226348-2014-11848
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    July 9, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK974739
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE VALVE AND CATHETER WERE RETURNED FOR EVALUATION. THE INVESTIGATION OF THE RETURNED VALVE DID CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER. THE LOT NUMBER FOR THE VALVE WAS CPNBZJ SERIAL NUMBER (B)(4), PRODUCT CODE 82-3184. THE LOT NUMBER FOR THE CATHETERS IS CRCC5W, PRODUCT CODE, 82-3072. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 70MMH2O. THE VALVE WAS VISUALLY INSPECTED; CUT MARKS IN THE SILICONE HOUSING OVER THE VALVE CASING WERE NOTED, ALSO A TEAR IN THE SILICONE HOUSING WAS NOTED AT THE FRONT OF THE NEEDLE CHAMBER, IT WAS ALSO NOTED THAT THE PROXIMAL CONNECTOR WAS BENT. THE VALVE WAS IRRIGATED; NO OCCLUSION WAS NOTED, EVEN WITH THE BENT CONNECTOR. THE CATHETERS WERE IRRIGATED WITH PURIFIED WATER, NO OCCLUSION WAS NOTED. THE VALVE WAS DRIED. THE VALVE WAS LEAK TESTED. THE VALVE LEAKED FROM THE TEAR IN THE SILICONE HOUSING. THE VALVE WAS REFLUX TESTED, THE VALVE PASSED THE TEST. THE VALVE WAS TESTED FOR PROGRAMMING, THE VALVE FAILED THE TEST; DURING THE PROGRAMMING PROCESS THE CAM MECHANISM DID NOT MOVE. THE VALVE WAS PRESSURE TESTED AND THE VALVE FAILED 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, ON THE CAM MECHANISM, ON THE CAM MECHANISM PILLAR, AND ON THE BASE PLATE. CUT MARKS WERE ALSO NOTED IN THE VALVE CASING. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE, PRODUCT CODE 82-3184 WITH LOT NUMBER CPNBZJ, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 8TH JANUARY 2014. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE CATHETERS, PRODUCT CODE 82-3072, WITH LOT NUMBER CRCC5W, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 5TH MARCH 2014. 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, ON THE CAM MECHANISM, ON THE CAM MECHANISM PILLAR, AND ON THE BASE PLATE. THE ROOT CAUSE FOR THE TEARS IN THE SILICONE HOUSING IS POSSIBLE DUE TO A SHARP/POINTED OBJECT OR MAY BE CLAMPS COMING INTO CONTACT WITH THE SILICONE HOUSING, AS NOTED IN THE IFU SILICONE HAS A LOW CUT AND TEAR RESISTANCE. THE ROOT CAUSE FOR THE BENT CONNECTOR IS PROBABLY DUE TO HUMAN ERROR, BUT THIS COULD NOT BE DETERMINED. NO PROBLEM WAS NOTED WITH THE CATHETERS. NO CORRECTIVE ACTION IS NEEDED BASED ON THE RESULTS OF THE EVALUATION. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    STOPPED FUNCTIONING AFTER IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433410 HAKIM PROGRAMMABLE VALVE, RT ANGLE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF CPNBZJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 82-3072