BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN EXTERNAL DRAINAGE SYSTEM III

    MDR report key: 2840111 · Received November 20, 2012

    Report

    Report Number
    1226348-2012-00598
    Event Type
    Injury
    Date Received
    November 20, 2012
    Date of Event
    October 28, 2012
    Manufacturer
    CODMAN AND SHURTLEFF - MEDOS
    Product Code
    JXG
    PMA / PMN Number
    K954021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE DEVICE WAS VISUALLY INSPECTED AND IT WAS NOTED THAT THE TUBING AT THE NEEDLESS PORT HAS COME AWAY FROM THE NEEDLESS PORT. HOWEVER, GLUE TRACES WERE FOUND ON THE TUBING AND IN THE NEEDLESS PORT. IT IS POSSIBLE THAT THE TUBING WAS PULLED AWAY FROM THE NEEDLESS PORT BUT THIS COULD NOT BE DETERMINED. THE CURRENT QUALITY TEST INSPECTION FOR THESE ASSEMBLIES IS ESTABLISHED TO FOR LEAKS AND BLOCKAGES. A REVIEW OF THE HISTORY DEVICE RECORDS CONFIRMED THE DEVICE CONFORMED TO THE SPECIFICATIONS PRIOR TO DISTRIBUTION. 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.

    Description of Event or Problem · 1

    AFFILIATE REPORTED THAT THERE WAS CSF LEAKING FROM THE LINE OF THE EDSIII AT THE STOPCOCK LEVEL. THERE WAS NO PATIENT MOVEMENT OR OTHER EXTERNAL EVENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CODMAN EXTERNAL DRAINAGE SYSTEM III SHUNT, CENTRAL NERVOUS SYSTEM COMPS JXG CODMAN AND SHURTLEFF - MEDOS CNDCDZ

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention