MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD NEXIVA DIFFUSICS; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number	383592
Health Effect - Clinical Codes	Air Embolism (1697); Stroke/CVA (1770); Feeding Problem (1850); Low Oxygen Saturation (2477); Thrombosis/Thrombus (4440); Cardiac Septal Defect Residual Shunt (4853)
Date of Event	08/07/2025
Type of Reportable Event	Death
Event or Problem Description
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.

• Brand Name: BD NEXIVA DIFFUSICS
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; one becton drive; franklin lakes NJ 07417
• MDR Report Key: 23423807
• Report Number: 23423807
• Device Sequence Number: 15514597
• Product Code: FOZ
• UDI-Device Identifier: 00382903835928
• UDI-Public: 00382903835928
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/08/2025
• Report Date (Section F): 09/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: 383592
• Device Catalogue Number: 383592
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/30/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/30/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 56 KG
• Date Report Sent to FDA: 09/09/2025