BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD NEXIVA CLOSED IV ACCESS SYSTEM

    MDR report key: 2232806 · Received August 25, 2011

    Report

    Report Number
    1710034-2011-00073
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 25, 2011
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SAMPLE IS AVAILABLE FOR EVAL. UPON RECEIPT OF THE SAMPLE AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE CLINICIAN ENTERED THE PT'S ROOM TO FIND THAT THE IV TUBING HAD COME APART FROM THE MAIN HUB AREA. THE DR ORDERED FOR THE IV TO BE DISCONTINUED. THE IV WAS REMOVED WITHOUT PROBLEMS AND CHARTED. SAVED CATHETER TO GIVE TO FLOOR MANAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BD NEXIVA CLOSED IV ACCESS SYSTEM INTRA VASCULAR CATHETER FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. NA 1047781

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Other