BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIFIX FX

    MDR report key: 2103110 · Received May 5, 2011

    Report

    Report Number
    2103110
    Event Type
    Malfunction
    Date Received
    May 5, 2011
    Date of Event
    April 15, 2011
    Report Date
    May 4, 2011
    Manufacturer
    B. BRAUN MEDICAL INC
    Product Code
    CAZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US

    Narratives

    Description of Event or Problem · 1

    WHEN REMOVING EPIDURAL CATHETHER, PLASTIC TIP SHEARED IN THE PATIENT'S BACK AND THE FILAMENT INSIDE THE PLASTIC CATHETER TIP UNWOUND AND BROKE, WITH A SMALL SECTION (ABOUT 2 CM) BEING RETAINED IN THE PATIENT; THIS WAS DISCOVERED DURING A SUBSEQUENT SPINAL ANESTHESIA PROCEDURE. PLASTIC PORTION OF THE CATHETER WAS FULLY REMOVED DURING CATHETER REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PERIFIX FX SPRINGWOUND EPIDURAL CATHETER CAZ B. BRAUN MEDICAL INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 30 YR NO OTHER THERAPIES