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

Model Number	383516
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/12/2025
Type of Reportable Event	Malfunction
Event or Problem Description
Proper insertion procedure was performed and iv inserted into patient to left ac [antecubital] with lab draw.While obtaining labs, port located below catheter was leaking blood.Flushed iv catheter and fluids were also leaking at same site.Attempted to troubleshoot connections of iv but catheter continued to leak; iv removed from patient intact.Demonstrated issue with charge nurse by flushing removed iv catheter and compared to another product of the same lot number that did not have this issue.Patient had to have another iv inserted due to first iv malfunction.No issues with new iv established with same lot number and no other issues with catheter during shift.

• Brand Name: BD NEXIVA
• Common Device Name: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY; 1 becton dr.; franklin lakes NJ 07417
• MDR Report Key: 23671506
• Report Number: 23671506
• Device Sequence Number: 9808201
• Product Code: FOZ
• UDI-Device Identifier: 00382903835164
• UDI-Public: (01)00382903835164
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 11/14/2025
• Report Date (Section F): 11/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 383516
• Device Catalogue Number: 383516
• Device Lot Number: 5187211
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 11/28/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/28/2025
• 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
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 60 KG
• Date Report Sent to FDA: 11/14/2025