BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA, BD Q-SYTE

    MDR report key: 22140312 · Received June 4, 2025

    Report

    Report Number
    22140312
    Event Type
    Malfunction
    Date Received
    June 4, 2025
    Date of Event
    April 25, 2025
    Report Date
    May 14, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    BD NEXIVA 22 GAUGE; IV CATHETERS WITH LOT #5003783 CAUSING NEEDLE STICKS. WE HAVE HAD OVER 6 IV STICKS WITH NO "FLASH" CAUSING UNNECESSARY TRAUMA AND NEEDLE STICKS. AGAIN, THIS NEEDS TO BE REPORTED TO THE MANUFACTURER. NURSES STARTED REPORTING THAT THEY WERE HAVING TO USE MULTIPLE STICKS BECAUSE THEY WERE NOT GETTING THE FLASH OF BLOOD THEY NEED TO MAKE SURE IT IS IN THE VEIN. OVER THE NEXT SEVERAL DAYS NURSES REPORTED THAT THIS WAS AN INTERMITTENT PROBLEM WITH A TOTAL OF 10 NOT FLASHING. IT WAS ALSO HAPPENING WITH ALL OF THE NURSES INCLUDING THOSE WITH MANY YEARS OF SERVICE. MANUFACTURER: BD NEXIVA, MODEL: NEXIVA IV CATHETER, LOT: 5003783, BRAND NAME: BD NEXIVA, DESCRIPTION OF DEVICE: 22 GA X 1.00IN (0.9X25MM), SUPPLIER: (B)(4). MANUFACTURER RESPONSE FOR IV CATHETER, NEXIVA IV CATHETER (PER SITE REPORTER). OFFERED TO REPLACE PRODUCT BUT NO OTHER ACTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778337 BD NEXIVA, BD Q-SYTE CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BECTON, DICKINSON AND COMPANY 383532 5003783

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown