BEUDAMED
    FDA Adverse Event Other Summary report: N

    TUN-L-XL PROCEDURAL KIT

    MDR report key: 394990 · Received May 16, 2002

    Report

    Report Number
    1316297-2002-00002
    Event Type
    Other
    Date Received
    May 16, 2002
    Date of Event
    May 2, 2002
    Report Date
    May 16, 2002
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Product Code
    CAZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DR. HAD COMPLETED LYSIS PROCEDURE AND WHEN HE WITHDREW THE CATHETER, HE NOTICED THAT IT HAD UNRAVELLED AND THE TIP OF THE CATHETER WAS MISSING. PATIENT WAS EXAMINED UNDER X-RAY AND IT WAS DISCOVERED THAT A SMALL SECTION OF THE CATHETER TIP (5MM) HAD REMAINED IN THE PATIENT'S EPIDURAL SPACE. DR. CHOSE TO LEAVE THE PIECE IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUN-L-XL PROCEDURAL KIT EPIDURAL CATHETER KIT CAZ EPIMED INTERNATIONAL, INC. NA 3140515

    Patients

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