BEUDAMED
    FDA Adverse Event Other Summary report: N

    TUN-L-XL EPIDURAL CATHETER

    MDR report key: 428612 · Received October 11, 2002

    Report

    Report Number
    1316297-2002-00003
    Event Type
    Other
    Date Received
    October 11, 2002
    Date of Event
    October 7, 2002
    Report Date
    October 11, 2002
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Product Code
    BSO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN WAS PERFORMING LYSIS PROCEDURE AND NOTICED DIFFICULTY IN POSITIONING CATHETER. THEN ATTEMPTED TO REMOVE CATHETER AND NOTICED IT HAD BEGUN TO UNRAVEL. CONTINUED IN REMOVAL OF CATHETER AND NOTICED THAT THE TIP OF THE CATHETER HAD REMAINED IN THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUN-L-XL EPIDURAL CATHETER EPIDURAL CATHETER BSO EPIMED INTERNATIONAL, INC. NA 1140406

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other RK NEEDLE, 16 GA.