BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIO-OPAQUE EPIDURAL CATHETER

    MDR report key: 578519 · Received February 21, 2005

    Report

    Report Number
    578519
    Event Type
    Malfunction
    Date Received
    February 21, 2005
    Date of Event
    February 17, 2005
    Report Date
    February 21, 2005
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Product Code
    BSO
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US

    Narratives

    Description of Event or Problem · 1

    A PHYSICIAN WAS ATTEMPTING TO THREAD THE CATHETER THROUGH THE NEEDLE INTO THE EPIDURAL SPACE AND REPORTED MEETING SOME RESISTANCE. UNDER FLUOROSCOPY, THE CATHETER APPEARED TO HAVE BENT. THE CATHETER WAS REMOVED AND THE TIP WAS FOUND TO BE SPLIT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RADIO-OPAQUE EPIDURAL CATHETER EPIDURAL CATHETER BSO EPIMED INTERNATIONAL, INC. * *

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR NO OTHER THERAPIES