BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA

    MDR report key: 6030753 · Received October 14, 2016

    Report

    Report Number
    6030753
    Event Type
    Malfunction
    Date Received
    October 14, 2016
    Date of Event
    September 11, 2016
    Report Date
    September 28, 2016
    Manufacturer
    BD
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    AFTER IV CATHETER WAS SET UP WITH IV FLUIDS INFUSING, IT WAS NOTED LEAKAGE SURROUND THE WHITE TIP OF CATHETER. DEVICE DISCONNECTED. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    680793 BD NEXIVA CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BD 6176858

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR