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

Catalog Number	383536
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device leaked.Radiology reported a leaking ref #383536 yesterday evening.Customer response on (b)(6) 2026.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.No patient harm, injury, complication or negative outcome occurred.The nurse had to insert a new iv.
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
No new information.
Additional Manufacturer Narrative
The complaint of a leak was confirmed, and the cause appeared to be manufacturing related.One photo and one 20g nexiva iv catheter were provided for investigation.A microscopic examination revealed that the tubing was found to be mis-seated and folded within the luer adapter, allowing leakage to occur.This condition is consistent with a manufacturing defect likely introduced during assembly.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: 24618826
• Report Number: 1710034-2026-00284
• Device Sequence Number: 13221912
• Product Code: FOZ
• UDI-Device Identifier: 00382903835362
• UDI-Public: (01)00382903835362(11)251001(17)280930(10)5274629
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2026

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: 5274629
• 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: 03/10/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 03/17/2026
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown