BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EPIDURAL CATHETER

    MDR report key: 1100547 · Received August 4, 2008

    Report

    Report Number
    MW5007893
    Event Type
    Malfunction
    Date Received
    August 4, 2008
    Date of Event
    July 30, 2008
    Report Date
    August 4, 2008
    Manufacturer
    B/BRAUN
    Product Code
    BSO
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    EPIDURAL CATHETER PLACED WITHOUT DIFFICULTY. ONCE INSERTED, REQUESTED TAPE TO SECURE TO SKIN, NOTICED THE CATHETER HAD FRACTURED INTO TWO PIECES. BOTH PIECES WERE REMOVED. A SECOND CATHETER WAS INSERTED WITHOUT DIFFICULTY AND THE PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT DISCOMFORT OR DISTRESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EPIDURAL CATHETER EPIDURAL CATHETER BSO B/BRAUN 60986973

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR