BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD NEXIVA CLOSED IV ACCESS SYSTEM

    MDR report key: 2161700 · Received July 8, 2011

    Report

    Report Number
    1710034-2011-00059
    Event Type
    Injury
    Date Received
    July 8, 2011
    Report Date
    July 8, 2011
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE MAY BE AVAILABLE FOR EVALUATION. ADDITIONAL INFO REGARDING THIS INCIDENT HAS BEEN REQUESTED. IF THE SAMPLE AND/OR ADDITIONAL INFO IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    THE EXTENSION TUBING DISCONNECTED FROM THE Y-ADAPTER DURING USE AND A NEW IV HAD TO BE STARTED.

    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 SYSTEMS NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other