BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAKIM PROG VALVE INLINE SIPHON GUARD

    MDR report key: 1243730 · Received November 25, 2008

    Report

    Report Number
    1226348-2008-00324
    Event Type
    Injury
    Date Received
    November 25, 2008
    Date of Event
    November 3, 2008
    Manufacturer
    CODMAN & SHURTLEFF, INC/ MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    K992173
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, IT WAS NOTED THAT THIS COMPLAINT HAS BEEN CONFIRMED. AS RECEIVED AND AFTER DECONTAMINATION, THE VALVE WAS VISUALLY INSPECTED. SOME DRY DEBRIS, CONSISTENT IN APPEARANCE WITH BIOLOGICAL DEBRIS, WAS OBSERVED AT DIFFERENT AREAS INSIDE THE HOUSING. THE DEVICE WAS SET AT 50MMH2O AS RECEIVED AND HAD BOTH CATHETERS STILL ATTACHED. NO DAMAGE AND/OR EVIDENCE OF IMPROPER USED WAS OBSERVED. THE VALVE WAS SUBMITTED TO A PROGRAMMING TEST. THE VALVE COULD NOT BE REPROGRAMMED. THEN, A FLOW TEST WITH PURIFIED WATER WAS PERFORMED. INITIALLY A SLIGHT RESISTANCE WAS OBSERVED BUT SUBSEQUENTLY, IT FLOWED WITHOUT ANY DIFFICULTIES. IT APPEARS THAT THE DRY BIOLOGICAL DEBRIS MAY HAVE INITIALLY STUCK THE RUBY BALL TO ITS SEAT AND CAUSED OR CONTRIBUTED TO THE DIFFICULTY OF MOVING THE PRESSURE SETTING MECHANISM DURING THE PROGRAMMING TEST. AFTER THE FLOW TEST, A NEW ATTEMPT WAS MADE TO REPROGRAM THE DEVICE. THIS TIME IT COULD BE PROGRAMMED AT DIFFERENT PRESSURE SETTING WITHOUT ANY DIFFICULTIES. A REVIEW OF THE DEVICE HISTORY RECORDS WAS CONDUCTED AND THE VERIFIED THIS PRODUCT CONFORMED TO THE REQUIRED SPECIFICATIONS WHEN RELEASED TO INVENTORY. IT APPEARS THAT THE DRY BIOLOGICAL DEBRIS MAY HAVE INITIALLY STUCK THE RUBY BALL TO ITS SEAT AND CAUSED OR CONTRIBUTED FOR THE DIFFICULTY OF MOVING THE PRESSURE SETTING MECHANISM DURING THE PROGRAMMING TEST. BASED ON THE RESULTS OF THIS INVESTIGATION NOT FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS OR SIMILAR COMPLAINTS. AT THE PRESENT TIME, THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    REP REPORTED THAT THE VALVE STOPPED WORKING BECAUSE OF WHAT LOOKED LIKE DEBRIS IN THE VALVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAKIM PROG VALVE INLINE SIPHON GUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC/ MEDOS S.A. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention