BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA 24 G 3/4 INCH

    MDR report key: 4699644 · Received April 10, 2015

    Report

    Report Number
    MW5042106
    Event Type
    Malfunction
    Date Received
    April 10, 2015
    Date of Event
    April 10, 2015
    Report Date
    April 10, 2015
    Manufacturer
    BECTON, DICKINSON AND CO.
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    DE, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    BD NEXIVA 24 GAUGE REF (B)(4). LOT #4112626 PLACED IN PATIENT'S VEIN. BLOOD LEAKED FROM THE JUNCTION OF THE NEEDLE TIP SHIELD AND THE TIP OF THE TRIANGLED STABILIZATION PLATFORM EVINCING A BREAK IN THE SYSTEM. DIAGNOSIS OR REASON FOR USE: VENOUS ACCESS FOR IV ANTIBIOTICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240330 NEXIVA 24 G 3/4 INCH NEXIVA 24 G 3/4 INCH FMI BECTON, DICKINSON AND CO. NEXIVA 4112626

    Patients

    Seq Age Sex Outcome Treatment
    1 BECTON DICKINSON 22 GAUGE ONE INCH INSYTE CATHETER