BEUDAMED
    FDA Adverse Event Other Summary report: N

    TUN-L-KATH EPIDURAL CATHETER

    MDR report key: 563961 · Received January 5, 2005

    Report

    Report Number
    1316297-2004-00001
    Event Type
    Other
    Date Received
    January 5, 2005
    Date of Event
    December 12, 2004
    Report Date
    January 3, 2005
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Product Code
    BSO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN HAD COMPLETED LYSIS PROCEDURE AND UPON ATTEMPTING TO REMOVE CATHETER, ENCOUNTERED RESISTANCE. WAS EVENTUALLY ABLE TO REMOVE THE CATHETER, BUT NOTICED THAT IT WAS NOT INTACT. HE OBSERVED UNDER FLUOROSCOPY THAT APPROX. A 2" SECTION OF THE CATHETER TIP HAD REMAINED IN THE PT. AFTER CONFERRING WITH ANOTHER PHYSICIAN, HE CHOSE TO LEAVE THE CATHETER SECTION IN THE PT. NO FURTHER COMPLICATIONS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUN-L-KATH EPIDURAL CATHETER EPIDURAL CATHETER BSO EPIMED INTERNATIONAL, INC. 155-1520 UNK

    Patients

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