BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEXIVA

    MDR report key: 2971581 · Received January 28, 2013

    Report

    Report Number
    2971581
    Event Type
    Malfunction
    Date Received
    January 28, 2013
    Date of Event
    January 17, 2013
    Report Date
    January 28, 2013
    Manufacturer
    BECKTON, DICKINSON AND COMPANY
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS IN ER, TAKEN TO CT FOR IMAGING. IV USED FOR INJECTION OF CONTRAST DYE. RN NOTED THAT THE ENTIRE TUBING FROM THE CATH TO THE 'Y' CONNECTOR OF THE IV HAD BULGED OUT. THE INFUSION PUMP DID NOT ALARM FOR HIGH PRESSURE. THIS IS PROBABLY RELATED TO HAVING DYE INJECTED. PATIENT DENIES ANY PAIN ASSOCIATED WITH THE IV CATH. I HAVE NO CLUE WHAT SHOULD HAVE HAPPENED. I DON'T KNOW WHAT COULD PREVENT THIS, STRONGER TUBING OR THICKER TUBING, I DON'T KNOW. THE PROBLEM IS THAT THESE IV'S HAVE TO BE REMOVED AND REPLACED WHEN THEY FAIL. WITH OUR OTHER IV'S ALL THAT WE HAVE TO DO IS CHANGE THE TUBING TO THE IV.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?IV ACCESS FOR ER PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    38417 NEXIVA CATHETER FOZ BECKTON, DICKINSON AND COMPANY 20 GAUGE, PINK *

    Patients

    Seq Age Sex Outcome Treatment
    1 13 YR PT WAS IN CT SCAN, HAD DYE INJECTED, RETURNED TO| ER AND IV TUBING WAS BULGING