BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM INLINE PROGRAMMABLE VALVE SG

    MDR report key: 3895191 · Received June 25, 2014

    Report

    Report Number
    1226348-2014-11758
    Event Type
    Malfunction
    Date Received
    June 25, 2014
    Date of Event
    June 6, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INITIAL MEDWATCH REPORTED THIS COMPLAINT AS A SERIOUS INJURY; THIS WAS INCORRECT AND THIS COMPLAINT IS BEING REPORTED AS A MALFUNCTION WITH THE FOLLOWING RATIONALE: BLOCKED VALVE IF NOT DETECTED INTER-OPERATIVELY COULD LEAD TO COMPLICATIONS FOLLOWING IMPLANTATION. THE DEVICE WAS RETURNED FOR EVALUATION. THE INVESTIGATION OF THE RETURNED DEVICE DID NOT CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER. THE LOT NUMBER IS CPNBHG SERIAL NUMBER (B)(4), PRODUCT CODE 82-3162. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 70MMH2O. THE VALVE WAS VISUALLY INSPECTED; A NEEDLE HOLE WAS NOTED IN THE NEEDLE CHAMBER, NO DEFECTS WERE NOTED. THE VALVE WAS IRRIGATED WITH PURIFIED WATER. NO OCCLUSION WAS NOTED. THE SIPHON GUARD WAS IRRIGATED WITH PURIFIED WATER, NO OCCLUSION WAS NOTED. THE VALVE WAS DRIED. THE VALVE WAS LEAK TESTED; ONLY LEAKED FROM THE NEEDLE HOLE IN THE NEEDLE CHAMBER, NO OTHER LEAKS WERE NOTED. THE VALVE WAS REFLUX TESTED, THE VALVE PASSED THE TEST. THE VALVE WAS TESTED FOR PROGRAMMING AND THE VALVE PASSED THE TEST. THE VALVE WAS THEN PRESSURE TESTED, THE VALVE PASSED THE TEST. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE, PRODUCT CODE 82-3162 WITH LOT NUMBER CPNBHG, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE (B)(6) 2013. NO ROOT CAUSE COULD BE DETERMINED, AS THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. 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.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE DEVICE WAS USED TO THE PATIENT WHO WAS (B)(6) OLD BABY ON (B)(6) 2014. IT WAS NOTED THAT FLUID DID NOT FLOW THROUGH THE DEVICE WHEN THE SURGEON CHECKED CSF FLOW AFTER CONNECTING THE VALVE AND THE CATHETER MANUFACTURED BY OTHER COMPANY. THE VALVE IN QUESTION WAS NOT IMPLANTED AND REPLACED TO THE ANOTHER DEVICE SINCE THE SURGEON SUSPECTED THE VALVE MIGHT BE OBSTRUCTED WITH DEBRIS. THERE WERE NO SURGICAL DELAY GREATER THAN 30 MIN AND NO ADVERSE CONSEQUENCES TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    371812 HAKIM INLINE PROGRAMMABLE VALVE SG SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF CPNBHG

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Required Intervention