BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    10-100SF UCSF

    MDR report key: 1230416 · Received November 7, 2008

    Report

    Report Number
    2648988-2008-00042
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 30, 2008
    Report Date
    November 6, 2008
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, 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 ON THE REPORTED INCIDENT.

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE RECEIVED A CALL FROM THE ICU EDUCATOR TELLING HER THAT THEY HAD A UNIT THAT WAS NOT DRAINING PROPERLY FROM THE DRIP CHAMBER INTO THE DRAINAGE BAG. THE EDUCATOR OF THE USER FACILITY SAID THEY TRIED A NUMBER OF MANIPULATIONS TO REMEDY THE PROBLEM, INCLUDING STRETCHING THE NECK OF THE BAG, REPLACING THE BAG, AND EVENTUALLY SUCTIONING SOME CEREBRAL SPINAL FLUID (CSF) OUT OF THE SIDE OF THE STOPCOCK AT THE BASE OF THE DRIP CHAMBER. IN THE END, SUCTIONING CSF WAS ABLE TO INITIATE FLOW THROUGH THE STOPCOCK AND EVENTUALLY INTO THE DRAINAGE BAG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 10-100SF UCSF EVD JXG INTEGRA NEUROSCIENCES PR SP0042 1081471

    Patients

    Seq Age Sex Outcome Treatment
    1