MAUDE Adverse Event Report: BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. NEXIVA; PERIPHERAL IV CATHETERS

Catalog Number	383519
Medical Device Problem Codes	Leak/Splash (1354); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
G.4.K183399; k243403.H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Event details: i went to do an iv for a ct exam.I pulled back on iv to prepare it for exam.It did feel a bit stiff and not as smooth as usual.However, i did proceed with the poke.The iv went in ok but once i hand flushed with 10ml of saline it felt a bit difficult to flush and blood appeared behind the wings.Pt.Said it felt ok.I then proceeded to try a power injector flush, and it immediately pressured out.There appeared to be a crack or something wrong with the iv.Removed and restarted with a new iv in the other arm.No apparent harm - reached the patient/person- inconvenient.

• Brand Name: NEXIVA
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer (Section G): BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.; 9450 south state street; sandy UT 84070
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 25539595
• Report Number: 1710034-2026-00666
• Device Sequence Number: 13177050
• Product Code: FOZ
• UDI-Device Identifier: 00382903835195
• UDI-Public: (01)00382903835195(11)251208(17)281130(10)5342285
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: SEE H.11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2026

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: Health Professional
• Device Catalogue Number: 383519
• Device Lot Number: 5342285
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2026
• Supplement Date Received by Manufacturer: Not provided; 07/06/2026
• Initial Report FDA Received Date: 06/17/2026
• Supplement Report FDA Received Date: 06/26/2026; 07/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown