BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEXIVA 22 GA X 1 IN SINGLE PORT 22 G IV CATHETER

    MDR report key: 23390063 · Received October 27, 2025

    Report

    Report Number
    MW5177964
    Event Type
    Malfunction
    Date Received
    October 27, 2025
    Report Date
    October 21, 2025
    Manufacturer
    BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    STAFF NOTED ON SEVERAL OCCASIONS THAT BD NEXIVA 22 GA X 1 IN SINGLE PORT IV CATHETERS WERE NOT PROVIDING FLASHBACK OF BLOOD, WHEN OTHER INDICATORS WERE SHOWING THAT THE CATHETER WAS APPROPRIATELY PLACED IN THE VEIN. PRODUCT SAMPLES WERE SENT TO BD FOR TESTING. RESULTS FROM MANUFACTURER TESTING INDICATED OCCLUSION BETWEEN THE FLASH NOTCH AND THE NEEDLE TIP. THE OCCLUSION WAS FOUND TO BE CONSISTENT WITH NON-FOREIGN MATERIAL USED DURING ASSEMBLY, SUCH AS LUBRICATE OR ADHESIVE. THE AFFECTED LOT NUMBERS NOTED INCLUDE 5003791 AND 5003789. THERE IS NO SUSPECTED HARM TO PATIENTS AT THIS TIME. REFERENCE REPORT: MW5177965.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2798566 BD NEXIVA 22 GA X 1 IN SINGLE PORT 22 G IV CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383512 5003791

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown