BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXT DRAINAGE SYSTEM III WITHOUT VENT CATH

    MDR report key: 3052188 · Received April 11, 2013

    Report

    Report Number
    1226348-2013-15170
    Event Type
    Injury
    Date Received
    April 11, 2013
    Date of Event
    March 14, 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 DURING TESTING THE SYSTEM WAS IRRIGATED AND BIOLOGICAL DEBRIS WAS FLUSHED FROM THE SYSTEM. DURING THE LEAK TEST, IT WAS FOUND THAT THERE WAS A LEAK AT THE FIRST THREE WAY CONNECTOR ON THE PROXIMAL SIDE CLOSEST TO THE PATIENT. THE TUBING WAS STILL IN PLACE AND COULD NOT BE PULLED OUT. IT MIGHT BE POSSIBLE THAT THE TUBING WAS BENT AND HAS CAUSED THE TUBING TO COME AWAY FROM THE GLUE, BUT THIS COULD NOT BE DETERMINED. THE CURRENT QUALITY INSPECTION FOR THESE ASSEMBLIES IS ESTABLISHED TO 100% TESTED FOR LEAKS AND BLOCKAGES, THEREFORE, THIS TYPE OF LEAKAGE WOULD HAVE BEEN DETECTED DURING THE MANUFACTURING INSPECTION PRIOR TO DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED 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

    THE AFFILIATE REPORTED THAT THERE WAS A LEAKAGE IN THE THREE WAY CONNECTOR. NO FURTHER DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    156425 EXT DRAINAGE SYSTEM III WITHOUT VENT CATH SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. CNJCJ8

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention