BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CODMAN EDS 3

    MDR report key: 1951431 · Received December 30, 2010

    Report

    Report Number
    1951431
    Event Type
    Malfunction
    Date Received
    December 30, 2010
    Date of Event
    December 13, 2010
    Report Date
    December 30, 2010
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD EVD (EXTERNAL VENTRICULAR DRAIN) IN PLACE FOR DRAINAGE OF CSF. DURING ROUTINE CARE, THE DRAIN CAME DISCONNECTED AT AN UNUSUAL SITE (OTHER THAN A NORMAL PLACE FOR DISCONNECTION) AND HAD TO BE REPLACED. THE RN WAS PRESENT BOTH TIMES AND WAS ABLE TO CLAMP THE DRAIN BEFORE ANY HARM CAME TO THE PATIENT. THE FIRST TIME IT BECAME DISCONNECTED AT THE STOPCOCK. THE SECOND TIME THE DRAIN BECAME DISCONNECTED WAS A DAY LATER AT THE LOCATION OF THE SAMPLING PORT. NO HARM TO THE PATIENT.====================== MANUFACTURER RESPONSE FOR EXTERNAL VENTRICULAR DRAIN, CODMAN EDS-3======================THEY HAVE REPLACED THE DRAINS AND THE REP HAS BEEN IN CONTACT WITH THEIR PRODUCTS/SAFETY REP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN EDS 3 SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG CODMAN & SHURTLEFF, INC. * 3145584, CLHCCO

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR