BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 2221394 · Received August 16, 2011

    Report

    Report Number
    2221394
    Event Type
    Malfunction
    Date Received
    August 16, 2011
    Date of Event
    July 19, 2011
    Report Date
    August 15, 2011
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DEPRESSED AREA ON IV ANGIOCATHETHER TUBING NOTED AFTER IV INSERTION, PREVENTING IV FLUID FROM ADVANCING INTO PATIENT'S VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXIVA CLOSED IV CATHETER SYSTEM FOZ BECTON, DICKINSON AND COMPANY * 1105274

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR