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

Catalog Number	383536
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that nexiva had a crack and leaked.Ed: iv placed in stroke patient via r ac by this rn.Iv port access site where you would attach vacutainer and clave is broken and leaking blood everywhere.No way of salvaging line.Piv had to be removed and pt had to be poked an additional time due to defective equipment.Also delayed care in a stroke patient.Additional information 13-apr-2026: sorry forgot to include luckily these didn't cause harm but caused minor delays to treatment.
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.
Additional Manufacturer Narrative
The complaint that blood was leaking from the connection was confirmed and the cause appeared to be manufacturing related.One 20g nexiva iv catheter was provided for investigation.The device was received with a q-syte connector attached to each luer adapter.Impressions were observed on one of the two dual port luer adapters, which pushed the material inward and caused the geometry on the inner surface of the female luer adapter to change.The damaged luer adapter prevented a proper connection between the q-syte connector and the pink adapter.The damage likely occurred during manufacturing and the appropriate manufacturing personnel were notified of this complaint.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Complaints received about this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the data collected for identification of emerging trends.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
Additional information added to b tab describe event or problem.
Event or Problem Description
Additional information 4/17/2026 no harm to patient.Delay was probably a couple of minutes as they had to stop treating the patient, get a new product, and start over.

• 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: 24915771
• Report Number: 1710034-2026-00431
• Device Sequence Number: 15934815
• Product Code: FOZ
• UDI-Device Identifier: 00382903835362
• UDI-Public: (01)00382903835362
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2026

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: 383536
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2026
• Supplement Date Received by Manufacturer: Not provided; 04/27/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 04/21/2026; 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/25/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown