BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NO WHITE CLAMP, NO ONE WAY VALVE AND A SEAMLESS

    MDR report key: 1881698 · Received October 6, 2010

    Report

    Report Number
    2648988-2010-00076
    Event Type
    Malfunction
    Date Received
    October 6, 2010
    Report Date
    October 6, 2010
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Description of Event or Problem · 1

    SECOND REPORT FROM THE SAME FACILITY, OF A HERMETIC EVD DRAIN SPECIAL NO WHITE CLAMP NO ONE WAY VALVE SEAMLESS SYSTEMS (B)(4); IT WAS REPORTED THAT THE UNIT WAS LEAKING CEREBROSPINAL FLUID. THE DRAIN WAS IN THE PATIENT FOR EIGHT DAYS WHEN IT STARTED TO LEAK ABOVE THE STOPCOCK (THE LOCATION WAS FOUND AT THE TUBING CONNECTING TO THE OPEN/CLOSE STOP/COCK). THE SYSTEM WAS CHANGED. THE PATIENT DID NOT INCUR ANY INJURY AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NO WHITE CLAMP, NO ONE WAY VALVE AND A SEAMLESS NONE JXG INTEGRA NEUROSCIENCES PR 110420

    Patients

    Seq Age Sex Outcome Treatment
    1