BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM INLINE PROGRAMMABLE VALVE SG

    MDR report key: 6052188 · Received October 24, 2016

    Report

    Report Number
    1226348-2016-10745
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    August 17, 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). IT WAS PREVIOUSLY REPORTED THAT THE DEVICE WOULD NOT BE RETURNED FOR EVALUATION. THE DEVICE WAS LATER RETURNED AND EVALUATED. THIS REPORTED HAS BEEN UPDATED TO REFLECT THE CORRECTED INFORMATION. THE DEVICE WAS RETURNED FOR EVALUATION TO CODMAN (B)(4). THE INVESTIGATION OF THE RETURNED DEVICES DID NOT CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 70MMH2O. THE VALVE WAS HYDRATED FOR 24 HOURS. THE VALVE WAS VISUALLY INSPECTED: NO DEFECTS WERE NOTED. THE VALVE WAS TESTED FOR PROGRAMMING. THE VALVE PASSED THE TEST. THE VALVE WAS FLUSHED. THE VALVE PASSED THE TEST NO OCCLUSION WAS NOTED. THE VALVE WAS LEAK TESTED AND ONLY LEAKED FROM THE NEEDLE HOLES OVER THE NEEDLE GUARD. THE CATHETER WAS IRRIGATED, NO OCCLUSION WAS NOTED. THE VALVE WAS REFLUX TESTED AND PASSED THE TEST. THE SIPHON GUARD WAS TESTED AND THE VALVE PASSED THE TEST. THE VALVE WAS DRIED. THE SIPHON GUARD WAS REMOVED. THE VALVE WAS THEN PRESSURE TESTED AND PASSED THE TEST. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3162 WITH LOT CTKB9R, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN 29TH SEPTEMBER 2015. NO ROOT CAUSE COULD BE DETERMINED, AS THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT PRESENT WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 1

    IT WAS NOT POSSIBLE TO INVESTIGATE THE COMPLAINT AS NO SAMPLE WAS RETURNED FOR EVALUATION. IF THE SAMPLE IS RETURNED IN THE FUTURE, THIS COMPLAINT WILL BE RE-OPENED AND EVALUATED. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3162, WITH LOT CTKB9R, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN (B)(6) 2015. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4). UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    THE PRODUCT FAILED TO OPERATE DURING PRE-IMPLANTATION CHECK. DURING THE PRE-IMPLANTATION CHECK THEY DISCOVERED THAT THE DEVICE COULDN'T BE PRIMED/FLUSHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    701413 HAKIM INLINE PROGRAMMABLE VALVE SG SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CTKB9R

    Patients

    Seq Age Sex Outcome Treatment
    1