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

Catalog Number	383512
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E.1.Characters limit is exceeded at facility name: (b)(6).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
It was reported that nexiva leaked at the septum."it was reported that leakage has occurred in the catheter septum during use.Puncture was performed to facilitate a contrast-enhanced ct scan.Backflow of blood was observed extending through the extension tube and slightly past the septum¿a phenomenon that should not, under normal circumstances, occur.Since the backflowing blood did not completely breach the septum or leak outward, the insertion procedure was continued, and the catheter was successfully placed.Following placement, as the backflowing blood still did not fully breach the septum or leak externally, the contrast-enhanced ct scan was carried out.The contrast-enhanced ct scan was completed without incident.However, after the scan was finished, when an iv line was connected to the catheter adapter and fluid infusion was initiated, the fluid leaked past the septum.".
Event or Problem Description
No new information.
Additional Manufacturer Narrative
The complaint of a leak was confirmed, and the cause appeared to be manufacturing related.Six photographs and one 22ga nexiva device were provided for investigation.The septum was noted to be deformed within the catheter adapter, which created a leak path and allowed fluid to leak from the adapter.A review of the inspection records and quality and manufacturing controls for the implicated lot indicated no related issues with the manufacturing process.The appropriate manufacturing personnel were notified of this complaint.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.

• 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: 24691082
• Report Number: 1710034-2026-00328
• Device Sequence Number: 9771118
• Product Code: FOZ
• UDI-Device Identifier: 00382903835126
• UDI-Public: (01)00382903835126(11)250529(17)280531(10)5148471
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: SEE H.11
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: 383512
• Device Lot Number: 5148471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 03/25/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown