BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA

    MDR report key: 5993238 · Received October 3, 2016

    Report

    Report Number
    5993238
    Event Type
    Malfunction
    Date Received
    October 3, 2016
    Date of Event
    September 20, 2016
    Report Date
    September 21, 2016
    Manufacturer
    BD
    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

    ED NURSE STARTED IV ON PATIENT, BD NEXIVA 18GAUGE. ONCE ACCESS WAS OBTAINED,THE END OF THE CATHETER WHERE THE NEEDLE RETRACTS DID NOT SEAL ALLOWING BLOOD TO LEAK OUT OF THE SYSTEM. THERE WAS NO INJURY TO THE PATIENT OR NURSE. IV CATHETER WAS THEN IMMEDIATELY REMOVED AND A NEW ONE USED TO START IV. REF# 383539, LOT# 6174745 EXP 5-31-2019.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    646973 BD NEXIVA CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM FOZ BD 6174745

    Patients

    Seq Age Sex Outcome Treatment
    1 NO.