FDA Adverse Event Death Summary report: N

BD NEXIVA DIFFUSICS IV CATHETER

MDR report key: 23073556 · Received September 17, 2025

Report

Report Number
MW5176151
Event Type
Death
Date Received
September 17, 2025
Date of Event
August 7, 2025
Report Date
September 11, 2025
Manufacturer
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.
Product Code
FOZ
Adverse Event
Yes
Report Source
Voluntary report
Reporter Location
GA, US
Reporter Occupation
501
Health Professional
Yes

Narratives

Description of Event or Problem · 0

(B)(6): ON (B)(6) 2025, PATIENT RM PRESENTED TO THE EMERGENCY DEPARTMENT (ED) VIA THE NURSE FIRST PROGRAM, ACCOMPANIED BY HIS DAUGHTER. HE WAS AMBULATORY UPON ARRIVAL. AFTER TRIAGE, HE WAS TAKEN TO AN ED EXAMINATION ROOM WHERE A REGISTERED NURSE (RN) INSERTED A 20-GAUGE NEXIVA DIFFUSICS IV CATHETER INTO HIS RIGHT FOREARM. THE PATIENT WAS TRANSPORTED TO IMAGING FOR A CT SCAN WITH CONTRAST OF THE THORAX, ABDOMEN, AND PELVIS. WITHIN TWO HOURS OF THE PATIENT RETURNING FROM THE IMAGING PROCEDURE, THE PATIENT'S CONDITION BEGAN TO DETERIORATE. THE RN WAS AT THE PATIENT'S BEDSIDE AND OBSERVED THE PATIENT SLUMPED OVER IN HIS WHEELCHAIR. WITH THE ASSISTANCE OF MULTIPLE STAFF MEMBERS, THE PATIENT WAS TRANSFERRED TO A STRETCHER AND TRANSPORTED TO IMAGING FOR A NON-CONTRAST HEAD CT AND C-SPINE. THE HEAD CT CONFIRMED THE PRESENCE OF AN AIR EMBOLISM. THE PATIENT'S CONDITION CONTINUED TO DETERIORATE, NECESSITATING INTUBATION AND THE PLACEMENT OF TWO ADDITIONAL IV CATHETERS BY THE RN STAFF. THE ADDITIONAL IVS WERE NEXIVA DIFFUSICS IV CATHETERS: AN 18-GAUGE CATHETER IN THE LEFT FOREARM AND A 20-GAUGE CATHETER IN THE RIGHT ANTECUBITAL REGION. THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO THE CRITICAL CARE UNIT (CCU) FOR FURTHER MANAGEMENT AND MONITORING. CCU COURSE: THE PATIENT WAS ADMITTED TO THE EMERGENCY ROOM SEEKING ASSISTANCE WITH PLACEMENT AND REPORTING A LOSS OF APPETITE AND POOR INTAKE. DURING THE EXAMINATION, THE PATIENT SUDDENLY BECAME UNRESPONSIVE AND REQUIRED INTUBATION. AN IMMEDIATE HEAD CT SCAN REVEALED AN AIR EMBOLUS, SUGGESTING A POSSIBLE DEEP VEIN THROMBOSIS (DVT) IN THE RIGHT ARM. THE PATIENT ADMITTED TO THE CRITICAL CARE UNIT ON (B)(6) AT 0533 ORALLY INTUBATED AND PLACED ON VENTILATOR. THE PATIENT'S ONGOING MANAGEMENT INCLUDED CLOSE MONITORING AND ADJUSTMENTS TO RESPIRATORY SUPPORT, NUTRITIONAL SUPPORT, AND OTHER CRITICAL CARE INTERVENTIONS AS NEEDED. FOLLOWING THIS, AN ULTRASOUND WAS ORDERED ON (B)(6) AND BOTH A CT SCAN AND A RIGHT ARM DOPPLER STUDY WERE PERFORMED AND WAS NEGATIVE FOR PE OR DVT. VASOPRESSORS WERE TITRATED TO OFF AND A REPEAT HEAD CT WAS CONDUCTED ON (B)(6). ON (B)(6), A HEAD CT WAS COMPLETED. MORNING ARTERIAL BLOOD GAS (ABG) RESULTS SHOWED ELEVATED PAO2 LEVELS, ALLOWING FOR THE INITIATION OF FIO2 WEANING. ON (B)(6), THE PATIENT WAS EXTUBATED, AND RESTRAINTS WERE DISCONTINUED. THE PATIENT WAS PLACED ON A HIGH-FLOW NASAL CANNULA (HFNC) AT 40 LITERS PER MINUTE (LPM) AND 50% OXYGEN CONCENTRATION. A SPEECH CONSULT WAS ORDERED FOR (B)(6) AS THE PATIENT WAS UNABLE TO WEAN OFF THE HFNC. AN ECHOCARDIOGRAM WAS PERFORMED, AND BY THE EVENING, THE SETTINGS ON THE HFNC WERE 50% OXYGEN AND 45 LPM. ON THE EVENING OF (B)(6), THE FOLEY CATHETER WAS NOTED TO BE LEAKING, BUT THERE WERE NO ORDERS TO CHANGE IT. THE TUBE FEEDING RATE WAS INCREASED TO REACH THE GOAL, COMMENCING ON (B)(6), WITH HFNC SETTINGS ADJUSTED TO 45% OXYGEN AND 40 LPM. ON (B)(6), THE FOLEY CATHETER WAS CHANGED. THE PATIENT HAD A WEAK COUGH AND WAS NOT TOLERATING CHEST PHYSIOTHERAPY (CPT) ON THE BED WELL. BY (B)(6), IT WAS NOTED THAT THE PATIENT NEEDED EXTRA LASIX, AND 2 LITERS WERE ADMINISTERED IN THE EVENING. THE PATIENT ALERTED AND ORIENTED TO THE PERSON, PLACE AND TIME AND EXPRESSED A DESIRE FOR SPIRITUAL CARE. THERE WERE NO SIGNIFICANT CHANGES NOTED IN THE PATIENT'S CONDITION DURING THE EVENING. ON (B)(6), HE REMAINED ON HI FLOW OXYGEN VIA NASAL CANNULA. ON (B)(6), A DISCUSSION WITH THE PHYSICIAN AND THE FAMILY PROGRESSED TO THE FAMILY'S DESIRE TO TRANSITION PATIENT TO COMFORT CARE/HOSPICE DUE TO THE LARGE RIGHT HEMISPHERIC CVA AND THE DEVELOPMENT OF A HIGH-GRADE GRAM-NEGATIVE BACTEREMIA LIKELY FROM PNEUMONIA AND LABORED BREATHING. THE NASOGASTRIC TUBE WAS DISCONTINUED.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
2640117 BD NEXIVA DIFFUSICS IV CATHETER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS FOZ BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. 383592

Patients

Seq Age Sex Outcome Treatment
1 Male Death