BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HERMETIC LUMBAR CATHETER, CLOSED TIP

    MDR report key: 2040359 · Received February 15, 2011

    Report

    Report Number
    2648988-2011-00009
    Event Type
    Malfunction
    Date Received
    February 15, 2011
    Report Date
    March 15, 2011
    Manufacturer
    INTEGRA, ANASCO
    Product Code
    JXG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AN INS-5010 / HERMETIC LUMBAR CATHETER CLOSED TIP WAS INVOLVED IN AN INCIDENT DESCRIBED AS; THE GUIDE WIRE REPORTEDLY WAS TELESCOPING, UNRAVELING OR DISINTEGRATING UPON WITHDRAWAL FROM THE PT. THERE WAS NO PT INJURY INVOLVED WITH THIS INCIDENT. IT IS UNK WHETHER THERE WAS A DELAY IN THE PROCEDURE AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HERMETIC LUMBAR CATHETER, CLOSED TIP NA JXG INTEGRA, ANASCO 1100699

    Patients

    Seq Age Sex Outcome Treatment
    1