BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN EXT DRAINAGE SYSTEM III WITHOUT VENT CATH

    MDR report key: 4861977 · Received June 23, 2015

    Report

    Report Number
    1226348-2015-10364
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    June 1, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    JXG
    PMA / PMN Number
    PK954021
    Adverse Event
    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 ,IT WAS NOTED THAT THE TUBING AND STOP COCKS WERE LEAK TESTED AND A LEAK WAS FOUND ON THE PATIENT LINE STOP COCK, A CRACK AND STRESS MARKS WERE NOTED IN THE STOP COCK PLASTIC, THIS IS DUE TO OVER TIGHTENING. THE CURRENT QUALITY INSPECTION FOR THESE ASSEMBLIES IS ESTABLISHED TO 100% TEST FOR LEAK AND BLOCKAGE. REVIEW OF THE HISTORY DEVICE RECORDS WAS NOT POSSIBLE AS THE LOT NUMBER WAS UNKNOWN. THE ROOT CAUSE OF THE PROBLEM REPORTED BY THE CUSTOMER IS DUE TO OVER TIGHTENING. 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

    EVD SYSTEM IS USED FOR BOTH ICP MONITORING AND DRAINAGE OF CSF. WHEN THE 3-WAY TAP (CLOSEST TO PATIENT) WAS CLOSED TO DRAINAGE AND OPENED TO MONITORING, CSF WAS OBSERVED TO BE LEAKING BY THE REGISTERED NURSE AND THE REGISTRAR. A NEW SAME LIKE SYSTEM WAS OBTAINED AND CONNECTED AND HAS FUNCTIONED CORRECTLY. THIS PROCESS INVOLVED OPENING A CLOSED SYSTEM WHICH SHOULD OTHERWISE REMAIN CLOSED DUE TO RISK OF INFECTION. NO ABNORMALITIES DETECTED, NO ADVERSE EVENT TO THE PATIENT. THE LOT NUMBER IS UNKNOWN HOWEVER IT IS A NEW GENERATION MODEL POST THE RETURN TO MARKET. PLEASE BE AWARE DUE TO THE TIME DIFFERENCE BETWEEN (B)(6) VERSUS THE U.S. COMPLAINTS THAT ARE RECEIVED ON THE SAME DAY THAT THEY ARE ENTERED APPEAR THAT THE COMPLAINT CREATED DATE OCCURRED BEFORE THE COMPLAINT NOTIFIED DATE. THIS IS ATTRIBUTED TO A SYSTEM ISSUE ASSOCIATED WITH THE TIME DIFFERENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    406806 CODMAN EXT DRAINAGE SYSTEM III WITHOUT VENT CATH SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. / MEDOS S.A.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention