BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INSYTE

    MDR report key: 31600 · Received January 25, 1996

    Report

    Report Number
    31600
    Event Type
    Malfunction
    Date Received
    January 25, 1996
    Date of Event
    December 6, 1995
    Report Date
    December 21, 1995
    Manufacturer
    DESERET MEDICAL, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT BROUGHT INTO ER BY AMBULANCE WITH LOSS OF CONSCIOUSNESS. IV STARTED BY AMBULANCE CREW. INITIAL IV WAS DISCONTINUED BY ICU NURSE WHO FOUND END OF CATHETER BROKEN OFF. X-RAY SHOWED TIP OF CATHETER LODGED IN SOFT TISSUE OF LEFT UPPER ARM. PHYSICIAN CHOSE NOT TO SURGICALLY REMOVE CATHETER TIP AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INSYTE IV CATHETER FOZ DESERET MEDICAL, INC. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other