BEUDAMED
    FDA Adverse Event Other Summary report: N

    INSYTE-W IV CATHETER

    MDR report key: 469931 · Received July 3, 2003

    Report

    Report Number
    1710034-2003-00040
    Event Type
    Other
    Date Received
    July 3, 2003
    Date of Event
    January 1, 2003
    Report Date
    April 24, 2003
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    INSERTED IN EMERGENCY IN LEFT FOREARM CLOSE TO THE PT'S WRIST. RN NOTED THAT BLEEDING OCCURRED AT THE DRESSING SITE. RN REMOVED TAPE TO EXAMINE SITE AND CATHETER APPEARED TO HAVE BROKEN OFF IN THE VESSEL. THE CATHETER WAS LOCATED IN THE LEFT LOWER LUNG. DETERMINATION WAS MADE BY THE DOCTOR NOT TO ATTEMPT RETRIEVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYTE-W IV CATHETER INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other OTHER MANUFACTURER'S EXTENSION TUBING.