BEUDAMED
    FDA Adverse Event Death Summary report: N

    BD NEXIVA DIFFUSICS

    MDR report key: 23423807 · Received October 30, 2025

    Report

    Report Number
    23423807
    Event Type
    Death
    Date Received
    October 30, 2025
    Date of Event
    August 7, 2025
    Report Date
    September 8, 2025
    Manufacturer
    BECTON, DICKINSON AND COMPANY
    Product Code
    FOZ
    UDI-DI
    00382903835928
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PATIENT WAS ADMITTED TO THE ED, AND A 20GA IV CATHETER WAS PLACED IN THE RIGHT FOREARM. THE PATIENT WAS, THEN, TRANSFERRED TO IMAGING TO RECEIVE A CT WITH CONTRAST, AND THE PREVIOUSLY PLACED 20GA IV CATHETER WAS CONNECTED TO THE CONTRAST INJECTOR. WHILE IN THE ED AND TWO HOURS AFTER THE INITIAL CT, THE PATIENT BEGAN TO DETERIORATE AND WAS BROUGHT BACK TO IMAGING FOR A HEAD CT WITHOUT CONTRAST. AN AIR EMBOLISM WAS CONFIRMED. PATIENT RETURNED TO ED, TWO ADDITIONAL IVS WERE PLACED (18GA-LEFT FOREARM AND 20GA-RIGHT ANTECUBITAL), DOCTOR INTUBATED THE PATIENT, AND THE PATIENT WAS LATER TRANSFERRED TO THE CRITICAL CARE UNIT (CCU) A FEW HOURS LATER. WHILE IN THE CCU, THE PATIENT RECEIVED A DOPPLER TO CONFIRM A DEEP VEIN THROMBOSIS (DVT) IN THE RIGHT ARM AND REPEAT CT SCANS WITHOUT CONTRAST OF THE HEAD. ADDITIONALLY, MEDICAL STAFF DISCOVERED A RIGHT TO LEFT SHUNT WHILE RECEIVING A ECHOCARDIOGRAM. PATIENT WAS EXTUBATED AND PLACED ON HIGH-FLOW OXYGEN BUT SHOWED SIGNS OF DEFICIT ON THE LEFT SIDE OF THE BODY. NEUROLOGY CONFIRMED A RIGHT-SIDED LARGE TERRITORY CEREBROVASCULAR ACCIDENT (CVA) DUE TO THE PRESENCE OF AN AIR EMBOLISM. PATIENT HAD NASOGASTRIC (NG) TUBES CONNECTED. THE REPORTING FACILITY HAS EXPERIENCED TWO ADDITIONAL ADVERSE EVENTS INVOLVING THE BD NEXIVA CLOSED IV CATHETER SYSTEM OF VARYING REFERENCE NUMBERS AND LOT NUMBERS. THE SPECIFIC LOT NUMBER IN EACH EVENT IS UNKNOWN. THE REPORTING FACILITY WOULD LIKE THE MANUFACTURER TO EVALUATE THE BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM FOR POTENTIAL QUALITY ISSUES THAT MAY CONTRIBUTE TO SIMILAR EVENTS IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1370559 BD NEXIVA DIFFUSICS CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BECTON, DICKINSON AND COMPANY 383592 00382903835928

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Death