BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA

    MDR report key: 6581214 · Received May 22, 2017

    Report

    Report Number
    6581214
    Event Type
    Malfunction
    Date Received
    May 22, 2017
    Date of Event
    May 9, 2017
    Report Date
    May 11, 2017
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    VA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    NURSE PLACED AN IV CATHETER IN PATIENT AND IT WAS DRIPPING BLOOD OUT THE BACK OF THE CATHETER AND THE DEVICE LOOKS LIKE IT IS MISSING SOMETHING, WHICH IS WHY THE BLOOD KEPT DRIPPING OUT THE BACK OF THE DEVICE. THE NURSE STARTED THE IV IN THE ED AND AS SOON AS SHE INSERTED IT BLOOD STARTED COMING OUT OF THE PORT. SHE WENT ON AHEAD AND DREW LABS WHILE IN THERE, BUT THEN IMMEDIATELY REMOVED THE IV. NOTHING WAS FLUSHED THROUGH OR INFUSED INTO THIS. NO PATIENT OR STAFF INJURY. IT'S A 20G LOT# 7040645 REF# 383537 EXP. 1-31-2020. MANUFACTURER RESPONSE FOR BD NEXIVA CLOSED IV CATHETER SYSTEM 20G, BD NEXIVA (PER SITE REPORTER). I HAVE NOT HEARD BACK FROM THEM YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    363962 BD NEXIVA CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BECTON, DICKINSON AND COMPANY 383537 7040645

    Patients

    Seq Age Sex Outcome Treatment
    1 NO