BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA

    MDR report key: 1013893 · Received February 28, 2008

    Report

    Report Number
    1013893
    Event Type
    Malfunction
    Date Received
    February 28, 2008
    Date of Event
    February 25, 2008
    Report Date
    February 28, 2008
    Manufacturer
    BD INFUSION THERAPY SYSTEMS, INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A 24 GAUGE NEXIVA CATHETER FRACTURED AT THE HUB, LEAKING RESULTED. THE IV WAS REMOVED WITHOUT INCIDENT. SLIGHT RAISED DISCOLORED AREA AT SITE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD NEXIVA CATHETER, IV, CLOSED FOZ BD INFUSION THERAPY SYSTEMS, INC. * 6164579

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR