BEUDAMED
    FDA Adverse Event Other Summary report: N

    TUN-L-XL/24 EPIDURAL CATHETER

    MDR report key: 428364 · Received November 18, 2002

    Report

    Report Number
    1316297-2002-00004
    Event Type
    Other
    Date Received
    November 18, 2002
    Date of Event
    November 12, 2002
    Report Date
    November 18, 2002
    Manufacturer
    EPIMED INTERNATIONAL, INC.
    Product Code
    BSO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    PHYSICIAN HAD COMPLETED CAUDAL PROCEDURE AND WAS ATTEMPTING TO REMOVE CATHETER. RESISTANCE WAS ENCOUNTERED. UPON REMOVAL, IT WAS OBSERVED THAT A SECTION OF THE CATHETER'S COATING WAS MISSING. PT OBSERVED UNDER FLUOROSCOPOY AND A SECTION OF THE CATHETER (REPORTED TO BE APPROX. 8" HAD REMAINED IN PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUN-L-XL/24 EPIDURAL CATHETER EPIDURAL CATHETER BSO EPIMED INTERNATIONAL, INC. 155-2542 1142618

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other KIMBERLY CLARK TUOHY NEEDLE.