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

Catalog Number	383537
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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
This system burst during injection.Response on (14-nov-2025) was the device being used on the patient when the problem occurred? - yes.Has the patient or user suffered any harm? if yes, please explain: the psychological impact of having to replace the catheter and repeat the examination with contrast injection.Was additional medical/medical intervention required? if yes, please explain - yes: need to replace a catheter and repeat the examination with contrast injection could you please specify the date of the event? 07/11/2025 around 1:45 am.
Additional Manufacturer Narrative
The complaint of a damaged extension tube was confirmed; however, the root cause could not be determined.One 20g nexiva iv catheter was provided with evidence of use.The extension tubing was ballooned.The damage likely occurred during use; however, the root cause could not be determined.This type of damage can occur if the catheter is kinked, obstructed, or pressurized beyond the pressure limit.No occlusions or manufacturing defects were identified on the returned sample.The instructions for use (ifu) indicate to avoid kinking or obstructing catheter during power injection.In the event of an occlusion, power injector pressure-limiting features may not prevent catheter failure.The ifu also indicates that the 22-18 ga (0.9-1.3 mm) devices are suitable for use with power injectors set to a maximum pressure of 300 psi (2068 kpa) when access ports not suitable for use with power injectors are removed.There were no other similar complaints from the implicated lot.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.
Event or Problem Description
No new information.

• 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: 23652530
• Report Number: 1710034-2025-01875
• Device Sequence Number: 4823985
• Product Code: FOZ
• UDI-Device Identifier: 00382903835379
• UDI-Public: (01)00382903835379(11)250521(17)280430(10)5141070
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2026

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: 383537
• Device Lot Number: 5141070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2025
• Supplement Date Received by Manufacturer: 01/14/2026
• Initial Report FDA Received Date: 11/25/2025
• Supplement Report FDA Received Date: 01/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown