BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 2240892 · Received September 7, 2011

    Report

    Report Number
    2240892
    Event Type
    Malfunction
    Date Received
    September 7, 2011
    Date of Event
    September 3, 2011
    Report Date
    September 7, 2011
    Manufacturer
    BECTON DICKINSON AND COMPANY
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US

    Narratives

    Description of Event or Problem · 1

    NURSE ATTEMPTED TO START IV ACCESS ON A PATIENT USING THE BD NEXIVA CLOSED IV CATHETER SYSTEM. PATIENT WAS A "HARD STICK" AND AFTER NURSE PLACED THE CATHETER IN VEIN AND WITHDREW INNER NEEDLE, SELF SEALING PORT DID NOT RESEAL, ALLOWING FLOW OF BLOOD. IV CATHETER REMOVED AND DISCARDED. PATIENT REQUIRED ADDITIONAL STICK TO START IV.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXIVA CLOSED IV CATHETER SYSTEM FOZ BECTON DICKINSON AND COMPANY 18 G *

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR