BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CSF DRAINAGE SYSTEM W/PATIENT LINE ONE WAY VALVE

    MDR report key: 1230456 · Received November 7, 2008

    Report

    Report Number
    2648988-2008-00043
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Report Date
    November 7, 2008
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    NURSE

    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 ON THE REPORTED INFORMATION. SEE SCANNED PAGE.

    Description of Event or Problem · 1

    A TOTAL OF THREE DRAINAGE DEVICES HAVE BEEN REPORTED AS NOT FUNCTIONING PROPERLY. THE CEREBRAL SPINAL FLUID (CSF) COLLECTS IN THE BURETROL BUT DOES NOT DRAIN INTO THE DRAINAGE COLLECTION BAG. ALL THREE SYSTEMS WERE CHANGED FOR ANOTHER DRAINAGE DEVICE (SAME STYLE) THAT WORKED PROPERLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CSF DRAINAGE SYSTEM W/PATIENT LINE ONE WAY VALVE EVD JXG INTEGRA NEUROSCIENCES PR 10-100 1082235

    Patients

    Seq Age Sex Outcome Treatment
    1