BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INS-8301 WITHOUT THE LOWER/PROXIMAL CSF ACCESS P

    MDR report key: 2182565 · Received July 5, 2011

    Report

    Report Number
    2648988-2011-00025
    Event Type
    Malfunction
    Date Received
    July 5, 2011
    Date of Event
    June 13, 2011
    Report Date
    July 5, 2011
    Manufacturer
    INTEGRA, ANASCO
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, 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

    SP0204 INS 8301 WITHOUT THE LOWER/PROXIMAL CSF; ANTI REFLUX FAILED. THE PT HAD THE DRAIN IN PLACE APPROXIMATELY ONE WEEK WHEN THE ANTI REFLUX VALVE FAILED. A CLOT WAS NOTED AROUND THE VALVE. A SECOND DRAIN WAS PLACED AND IT FAILED IMMEDIATELY. BLOOD RESIDUE WAS NOT FOUND AROUND THE SECOND VALVE. A THIRD VALVE WAS PLACED. AS OF (B)(4) 2011, THE PT REMAINED IN THE INTENSIVE CARE UNIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INS-8301 WITHOUT THE LOWER/PROXIMAL CSF ACCESS P N/A JXG INTEGRA, ANASCO POSSIBLY 1110546 OR 111

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention