BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTA, 100ML DRIP CHAMBER

    MDR report key: 1021170 · Received March 28, 2008

    Report

    Report Number
    2021898-2008-00078
    Event Type
    Injury
    Date Received
    March 28, 2008
    Date of Event
    February 27, 2008
    Report Date
    February 27, 2008
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    PMA / PMN Number
    K983799
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE NURSE INADVERTENTLY INJECTED 200 CCS OF MEDICATION INTO THE THREE-WAY STOPCOCK ON THE PT LINE NEAREST TO THE EVD CATHETER. THE MEDICATION WAS INTENDED TO BE INJECTED INTO A DIFFERENT DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTA, 100ML DRIP CHAMBER 84JXG JXG MEDTRONIC NEUROSURGERY NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1