BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN HAKIM MICRO II VALVE

    MDR report key: 3935572 · Received July 15, 2014

    Report

    Report Number
    1226348-2014-11817
    Event Type
    Malfunction
    Date Received
    July 15, 2014
    Date of Event
    July 7, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    Product Code
    JXG
    PMA / PMN Number
    PK091346
    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 INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    THE VALVE WAS RETURNED FOR EVALUATION . THE INVESTIGATION OF THE RETURNED VALVE DID CONFIRM THE PROBLEM REPORTED BY THE CUSTOMER. THE LOT NUMBER WAS 360427, SERIAL NUMBER (B)(4), PRODUCT CODE NS5027. THE VALVE IS A PRECISION VALVE WITH 2 DOTS. THE VALVE WAS VISUALLY INSPECTED; AND CONFIRMED THAT THE BASE OF THE RICKHAM RESERVOIR HAS COME AWAY FROM THE TOP OF THE RICKHAM RESERVOIR, NO DAMAGE WAS FOUND WITH THE TWO PARTS OF RICKHAM RESERVOIR, THIS IS POSSIBLE DUE TO WRONG HANDLING. REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE VALVE, PRODUCT CODE NS5027 WITH LOT NUMBER 360427, CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK ON THE 23RD APRIL 2013. THE ROOT CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER IS PROBABLY DUE TO WRONG HANDLING, BUT THIS COULD NOT BE DETERMINED. NO CORRECTIVE ACTION IS NEEDED BASED ON THE RESULTS OF THE EVALUATION. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED.

    Description of Event or Problem · 1

    IT IS ALLEGED THAT THE VALVE CAME APART INTRA OP . ALL PIECES WERE ACCOUNTED FOR. A NEW VALVE WAS USED INSTEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    412494 CODMAN HAKIM MICRO II VALVE SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF 360427

    Patients

    Seq Age Sex Outcome Treatment
    1