BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISION VALVE INLINE, SIPHONGUARD

    MDR report key: 3999940 · Received August 11, 2014

    Report

    Report Number
    1226348-2014-11881
    Event Type
    Malfunction
    Date Received
    August 11, 2014
    Date of Event
    August 4, 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

    THIS REPORT WAS FILED TO INCLUDE ADDITIONAL INFORMATION RECEIVED FROM THE AFFILIATE. UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE VALVE IS A PRECISION VALVE WITH 3 DOTS. THE VALVE WAS VISUALLY INSPECTED; NO DEFECTS WERE NOTED. THE VALVE WAS IRRIGATED WITH PURIFIED WATER. NO OCCLUSION WAS NOTED. THE SIPHON GUARD WAS IRRIGATED WITH PURIFIED WATER, NO OCCLUSION WAS NOTED. THE VALVE WAS DRIED. THE VALVE WAS LEAK TESTED. NO LEAKS WERE NOTED. THE VALVE WAS REFLUX TESTED, THE VALVE PASSED THE TEST. THE VALVE WAS THEN PRESSURE TESTED, THE VALVE PASSED THE TEST. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE, PRODUCT CODE 82-3813, WITH LOT NUMBER CPPBWR, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 31ST JANUARY 2014. NO ROOT CAUSE COULD BE DETERMINED, AS NO PROBLEM WAS FOUND WITH THE VALVE. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    ON 8/11/2014 ADDITIONAL INFORMATION FROM THE AFFILIATE STATED: PLEASE SEE BELOW ANSWERS OF YOUR QUESTIONS. WAS THE DEFECTIVE DEVICE FOUND INTRAOPERATIVELY? DEFECTIVE DEVICE FOUND DURING USE ON PATIENT BY CONTROLLING SYSTEM VALVE. WAS THE PATIENT CLOSED AND REOPENED? NO. RESERVE SHUNT WAS OPENED. WAS THERE A DELAY IN SURGERY GREATER THAN 30 NO. PLEASE SEE TRACKING NUMBER, (B)(4).

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED: DURING SHUNT OPERATION, IT WAS OBSERVED THAT THE VALVE TAKEN FROM KIT DID NOT WORK. REPLACE WITH NEW ONE. (DURING USE ON PATIENT)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477113 PRECISION VALVE INLINE, SIPHONGUARD SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CPPBWR

    Patients

    Seq Age Sex Outcome Treatment
    1