BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA CLOSED IV ACCESS SYSTEM

    MDR report key: 1132384 · Received August 22, 2008

    Report

    Report Number
    9610847-2008-00072
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Report Date
    August 12, 2008
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. DATE SUBMITTED: 21 AUGUST 2008.

    Description of Event or Problem · 1

    THE NURSE WENT TO CRIMP THE TUBING AND IT SEPARATED FROM THE CONNECTOR.

    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 8008402

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK