BEUDAMED
    FDA Adverse Event Other Summary report: N

    BD NEXIVA CLOSED IV ACCESS SYSTEM

    MDR report key: 1003824 · Received February 26, 2008

    Report

    Report Number
    1710034-2008-00010
    Event Type
    Other
    Date Received
    February 26, 2008
    Date of Event
    January 10, 2008
    Report Date
    January 16, 2008
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONE USED UNIT WAS RECEIVED ON 22 JANUARY, 2008 AND IS CURRENTLY BEING DECONTAMINATED. ATTEMPTS HAVE BEEN MADE TO OBTAIN ADDITIONAL INFORMATION. UPON DECONTAMINATION AND COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE TUBING OF THE BD NEXIVA BROKE APART JUST BELOW THE SECUREMENT PLATFORM WHILE REMOVING THE CATHETER FROM THE PATIENT.

    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