BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM VENTRICUALR & PERITONEAL CATHETERS WITH BACTISEAL

    MDR report key: 6538221 · Received May 2, 2017

    Report

    Report Number
    1226348-2017-10299
    Event Type
    Injury
    Date Received
    May 2, 2017
    Date of Event
    March 25, 2017
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K003322
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    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. A SEARCH FOR RELATIVE COMPLAINT FOR THE SAME ISSUE WAS NOT POSSIBLE AS THE LOT NUMBERS WERE UNKNOWN FOR BOTH DEVICES. REVIEW OF THE HISTORY DEVICE RECORDS FOR THE VALVE WAS NOT POSSIBLE AS THE LOT NUMBER WAS UNKNOWN. REVIEW OF THE HISTORY DEVICE RECORDS FOR THE BACTISEAL CATHETER WAS NOT POSSIBLE AS THE LOT NUMBER WAS UNKNOWN. 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. DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE IMAGES WERE TAKEN OF THE VALVE ¿AS RECEIVED¿. THE VALVE WAS VISUALLY INSPECTED; NO DEFECTS NOTED. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS 70MMH2O. THE VALVE WAS HYDRATED. THE VALVE WAS TESTED FOR PROGRAMMING WITH PROGRAMMER 82-3126 WITH SERIAL NUMBER (B)(4), THE VALVE PASSED THE TEST. THE VALVE WAS FLUSHED, THE VALVE PASSED THE TEST NO OCCLUSION WAS NOTED. THE VALVE WAS LEAK TESTED, NO LEAKS NOTED. THE CATHETERS WERE IRRIGATED, NO OCCLUSIONS WERE NOTED. THE VALVE WAS REFLUX TESTED. THE VALVE PASSED THE TEST. THE SIPHON GUARD WAS TESTED. THE VALVE PASSED THE TEST. THE VALVE WAS DRIED. THE SIPHON GUARD WAS REMOVED. THE VALVE WAS THEN PRESSURE TESTED, THE VALVE PASSED THE TEST. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3115, WITH LOT CPLCB1, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 21ST OCTOBER 2013. REVIEW OF THE HISTORY DEVICE RECORDS FOR THE CATHETER WAS NOTE POSSIBLE AT THE LOT NUMBER WAS UNKNOWN. NO ROOT CAUSE COULD BE DETERMINED, AS THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. 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.

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    IT WAS PREVIOUSLY REPORTED THAT THE DEVICE WOULD NOT BE RETURNED. SUBSEQUENTLY THE DEVICE WAS PROVIDED FOR EVALUATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    SHUNT IMPLANTED AND FOUND NOT WORKING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    319404 HAKIM VENTRICUALR & PERITONEAL CATHETERS WITH BACTISEAL SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention