BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM IN LINE PROGRAMMABLE VALVE

    MDR report key: 6055092 · Received October 25, 2016

    Report

    Report Number
    1226348-2016-10746
    Event Type
    Malfunction
    Date Received
    October 25, 2016
    Date of Event
    October 1, 2016
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K974739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THE IMAGES WERE TAKEN OF THE ¿AS RECEIVED¿ VALVE. THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT 90MMH2O. THE VALVE WAS HYDRATED FOR 24 HOURS. THE VALVE WAS VISUALLY INSPECTED: A TEAR IN THE SILICONE HOUSING WAS NOTED, AS WELL AS ABRASIONS MARKS IN THE SILICONE HOUSING OVER THE VALVE CASING. THIS IS COULD BE DUE TO UNSHOD FORCEPS BEING USED. NO DEFECTS WERE NOTED WITH THE BACTISEAL CATHETER. THE VALVE WAS FLUSHED, FAILED LEAKED FROM TEAR/CUT IN SILICONE HOUSING. THE VALVE WAS LEAK TESTED, FAILED LEAKED FROM TEAR/CUT IN SILICONE HOUSING. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3162, WITH LOT CVDBNC, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK IN 28TH APRIL 2016. THE ROOT CAUSE TO THE TEAR/CUT IN THE SILICONE HOUSING IS PROBABLY BEING DUE TO THE USER, THIS HOWEVER COULD NOT BE DETERMINED. AS NOTED IN THE IFU SILICONE HAS A LOW TEAR / CUT RESISTANCE. PER HHE, IT HAS BEEN CONCLUDED THAT SILICONE HOUSING TEARS ARE NOT DESIGN RELATED, IN ORDER FOR THE HOUSING TEAR TO OCCUR THE USER HAS TO COMPROMISE THE SILICONE THROUGH A NICK OR TEAR IN ORDER FOR THE EVENT TO OCCUR. VALIDATION TESTING DEMONSTRATES A ROBUST DESIGN. TESTING HAS SHOWN THAT IF THE SILICONE HOUSING HAS BEEN COMPROMISED, A HOUSING TEAR IS LIKELY TO OCCUR. NO DEFECTS WERE NOTED WITH THE BACTISEAL CATHETER. 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

    TODAY WHILE DOING A PROGRAMMABLE SHUNT IN (B)(6) HOSPITAL, THE CLINICIAN FOUND THAT THERE WAS A LEAKAGE FROM THE SIDE OF THE CHAMBER WHICH IS VERY UNUSUAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    705885 HAKIM IN LINE PROGRAMMABLE VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A. CVDBNC

    Patients

    Seq Age Sex Outcome Treatment
    1 82-3072