MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH NEARPORT¿ IV ACCESS; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	393526
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2026
Type of Reportable Event	Malfunction
Event or Problem Description
20g nexiva nearport needle was defective and did not cover the bevel of the needle upon retraction.

• Brand Name: BD NEXIVA¿ CLOSED IV CATHETER SYSTEM WITH NEARPORT¿ IV ACCESS
• 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: 24144091
• Report Number: 24144091
• Device Sequence Number: 8997854
• Product Code: FOZ
• UDI-Device Identifier: 00382903935260
• UDI-Public: (01)00382903935260
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/08/2026
• Report Date (Section F): 01/08/2026

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
• Operator of Device: Other
• Device Model Number: 393526
• Device Catalogue Number: 393526
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 01/22/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/22/2026
• 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: 56 YR
• Patient Sex: Male
• Date Report Sent to FDA: 01/08/2026