BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EDS III CSF DRAIN SYS W/O V CATH

    MDR report key: 3123900 · Received May 22, 2013

    Report

    Report Number
    1226348-2013-17394
    Event Type
    Injury
    Date Received
    May 22, 2013
    Date of Event
    April 29, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    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, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE DEVICE WAS LEAK TESTED AND A LEAK WAS FOUND AT THE TOP OF THE DRIP CHAMBER ON BOTH EDS III UNITS. UPON FURTHER EXAMINATION UNDER APPROPRIATE MAGNIFICATION IT WAS OBSERVED THAT THE GLUE WAS NOT APPLIED ALL THE WAY ROUND THE TUBING. THIS MAY HAVE CONTRIBUTED TO THE PROBLEM ENCOUNTERED BY THE CUSTOMER. HOWEVER THIS COULD NOT BE CONFIRMED. THIS PROCESS HAS BEEN REVIEWED WITH THE NECESSARY TEAMS INVOLVED IN THE MANUFACTURING PROCESS. A REVIEW OF THE HISTORY DEVICE RECORDS DID NOT REVEAL ANY NON CONFORMANCES DURING MANUFACTURING. 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 IT WAS NOTICED THAT LEAKAGE OCCURRED ON THE SIDE CONNECTING THE TWO WAY STOP COCK. THREE DEVICES, TWO WITH THE SAME LOT NUMBER AND ONE WITH A DIFFERENT LOT WERE INVOLVED WITH THE SAME PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226011 EDS III CSF DRAIN SYS W/O V CATH SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CNMC08

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention