BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAKIM PROG VALVE INLINE SIPHONGUARD

    MDR report key: 3594927 · Received January 28, 2014

    Report

    Report Number
    1226348-2014-11178
    Event Type
    Malfunction
    Date Received
    January 28, 2014
    Date of Event
    January 13, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK992173
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 POSITION OF THE CAM WHEN THE VALVE WAS RECEIVED WAS 120MMH2O. THE CONNECTOR AND SILICONE HOUSING WERE EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION; THE CONNECTOR AND THE MOLDED SILICONE HOUSING WERE NOT DAMAGED. IT DOES HOWEVER REVEAL THAT THE SILICONE HOUSING HAS TAKEN THE FORM OF THE CONNECTOR. THE CONNECTORS ARE MOLDED INTO THE SILICONE HOUSING A PULL TEST IS DONE ON EACH LOT (3 VALVES PER LOT ARE TESTED). THE VALVES ARE ALSO TESTED AT 100% FOR LEAKS. A REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION. BASED ON THE RESULTS IT MIGHT BE LIKELY THAT THE PROBLEM REPORTED BY THE CUSTOMER MAY HAVE RESULTED FROM USER HANDLING. THIS HOWEVER COULD NOT BE CONFIRMED. 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

    THE AFFILIATE REPORTED: DURING THE IMPLANTATION OF THE VALVE AND THE PULL THROUGH OF THE PERITONEAL CATHETER, THE ADAPTER DISSOLVED FROM THE VALVE IT LOOKS LIKE THR TUBE RUPTURED. MDV DECISION NOT YET MADE AS I ASKED IF THE SURGERY SIGNIFICANTLY PROLONGED. ADDITIONAL INFORMATION FROM THE AFFILIATE STATED: WE RECEIVED FURTHER INFORMATION ABOUT THE A.M. COMPLAINT. THE LOT NUMBER IS CNL CZ 6. AND SHE TOLD US THAT THERE WAS NO DELAY IN SURGERY GREATER THAN 30 MIN, THUS WE CONSIDER THIS COMPLAINT AS NON MDV REPORTABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    60741 HAKIM PROG VALVE INLINE SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CNLCZ6

    Patients

    Seq Age Sex Outcome Treatment
    1