BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA HF

    MDR report key: 1396184 · Received May 21, 2009

    Report

    Report Number
    1396184
    Event Type
    Malfunction
    Date Received
    May 21, 2009
    Date of Event
    May 21, 2009
    Report Date
    May 21, 2009
    Manufacturer
    BD
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    THE NURSE WAS UNABLE TO REMOVE THE STYLET FROM THE BD NEXIVA CLOSED IV CATHETER AFTER SUCCESSFUL INSERTION. THE CATHETER NEEDED TO BE REMOVED AND A NEW ONE WAS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEXIVA HF CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM FOZ BD * *

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR