BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA CLOSED IV ACCESS SYSTEM

    MDR report key: 1213226 · Received October 22, 2008

    Report

    Report Number
    9610847-2008-00080
    Event Type
    Malfunction
    Date Received
    October 22, 2008
    Report Date
    October 7, 2008
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEM
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE WAS RECEIVED ON 14 OCT 2008, AND IS CURRENTLY BEING DECONTAMINATED. UPON DECONTAMINATION AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B) (4). (B) (4).

    Description of Event or Problem · 1

    THE TUBE DETACHED FROM THE NEXIVA CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD NEXIVA CLOSED IV ACCESS SYSTEM INTRAVASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEM NA 7333852

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK SODIUM