BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHLON IV

    MDR report key: 210430 · Received February 12, 1999

    Report

    Report Number
    210430
    Event Type
    Injury
    Date Received
    February 12, 1999
    Date of Event
    February 8, 1999
    Report Date
    February 10, 1999
    Manufacturer
    CRITIKON J & J MEDICAL INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ON 2/8/99 AT 1400, PT WAS FOUND OUT FROM BED WITH IV SITE AT RIGHT FOREARM, SWOLLEN WITH REDNESS. UPON REMOVING THE CATHETER, ONLY 3/4 OF THE CATHETER CAME OUT AND APPROX 0.5 TO 1CM OF THE CATHETER TIP WAS ENLODGED IN THE VEIN. A NON-RADIOPAQUE IV CATHETER WAS USED, ITS LOCATION CANNOT BE SEEN BY X-RAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHLON IV Implant INTRAVENOUS CATHETER (NON-RADIOPAQUE FEP POLYMER) FOZ CRITIKON J & J MEDICAL INC. * 3206K64

    Patients

    Seq Age Sex Outcome Treatment
    1 97 YR Life Threatening