BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PV-INLINE W/SG [MH]

    MDR report key: 4545920 · Received February 25, 2015

    Report

    Report Number
    1226348-2015-10114
    Event Type
    Malfunction
    Date Received
    February 25, 2015
    Date of Event
    February 10, 2015
    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

    AFFILIATE PROVIDED AN UPDATED LOT NUMBER. UPON COMPLETION OF THE INVESTIGATION A FOLLOW UP REPORT WILL BE FILED.

    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. NO ROOT CAUSE COULD BE DETERMINED SINCE NO SAMPLE WAS RETURNED FOR EVALUATION. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE PRODUCT CODE 82-3013, WITH LOT CNMCMM, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 19TH NOVEMBER 2012. 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 VALVE IS A PRECISION VALVE WITH 4 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 CATHETERS WERE IRRIGATED WITH PURIFIED WATER, NO OCCLUSION WAS NOTED. THE VALVE WAS DRIED. THE VALVE WAS LEAK TESTED. NO LEAKS WERE NOTED. THE SIPHON GUARD WAS REMOVED. THE VALVE WAS THEN PRESSURE TESTED. THE VALVE PASSED THE TEST. NO ROOT CAUSE COULD BE DETERMINED, AS THE PROBLEM REPORTED BY THE CUSTOMER COULD NOT BE DUPLICATED. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE, PRODUCT CODE 82-3814, WITH LOT NUMBER CRDBG5, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE ON THE 9TH APRIL 2014. 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.

    Description of Event or Problem · 1

    DURING THE V-P SURGERY, THE SURGEON IMPLANTED A VALVE BUT NOTED IT DIDN'T WORK. THE SURGEON SUSPECTED IT WAS OBSTRUCTED OR BROKEN. CHANGED (B)(4) TO COMPLETE THE SURGERY. THERE WAS NO REPORT ON PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    132401 PV-INLINE W/SG [MH] SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CRDBG5

    Patients

    Seq Age Sex Outcome Treatment
    1