BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INS5010 WITH XMAS TREE ADAPTER AND TUOHY NEEDLE

    MDR report key: 2241209 · Received August 18, 2011

    Report

    Report Number
    2648988-2011-00032
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Report Date
    August 18, 2011
    Manufacturer
    INTEGRA
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT EXPECTED TO BE RECEIVED FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFO.

    Description of Event or Problem · 1

    A SP0224 WAS REPORTED TO HAVE THE LUMBAR CATHETER BECOME DISCONNECTED FROM THE LUER PIN CONNECTOR. AS A RESULT, THERE WAS CEREBROSPINAL FLUID THAT DRAINED OUT, BUT THERE WAS NO INJURY TO THE PT. THE UNIT HAD TO BE REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INS5010 WITH XMAS TREE ADAPTER AND TUOHY NEEDLE NA JXG INTEGRA NOT KNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1