BEUDAMED
    FDA Adverse Event Other Summary report: N

    BREVI-XL EPIDURAL CATHETER

    MDR report key: 432657 · Received December 13, 2002

    Report

    Report Number
    1316297-2002-00005
    Event Type
    Other
    Date Received
    December 13, 2002
    Date of Event
    December 5, 2002
    Report Date
    December 11, 2002
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Product Code
    BSO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR WAS PERFORMING LYSIS PROCEDURE AND WAS EXPERIENCING DIFFICULTY IN MANEUVERING CATHETER. ATTEMPTED TO REMOVE CATHETER AND CATHETER HAD BEEN SHEARED AND WAS BEGINNING TO UNRAVEL. A 2-3 INCH SECTION OF THE CATHETER TIP WAS 'STUCK' IN THE PATIENT AND WAS REMOVED AFTER AN INCISION WAS MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BREVI-XL EPIDURAL CATHETER EPIDURAL CATHETER BSO EPIMED INTERNATIONAL, INC. 155-2340 1140760

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other RK EPIDURAL NEEDLE.