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	03/05/2026
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
It was reported that leakage occurred."on a couple of occasions there are links (leaks) " additional information (b)(6) 2026: the issue happened during patient use, there were no patient at risk of injury (b)(6) 2026.Leakage from the y adapter.
Event or Problem Description
Additional information as mentioned ¿total 23 qty,¿ could you please clarify whether this refers to 23 samples available for testing or 23 faulty devices that were identified? response received on 23-mar-2026: the 23 total are the same lots that we were having issues with.
Additional Manufacturer Narrative
Investigation results: the complaints of a damaged dual port luer adapter and that the needle could not be removed were confirmed and the damage appeared to be manufacturing related.Three photographs and twenty five 20g nexiva devices were provided for investigation.Deformation was observed on the pink dual port luer adapter that was displayed in the photographs.None of the returned physical samples exhibited damage to the luer adapter.One of the returned physical samples exhibited damage to the tip shield, which inhibited release of the needle from the catheter adapter.Two separate devices with different failure modes were confirmed from the sample analysis.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: 24607253
• Report Number: 1710034-2026-00279
• Device Sequence Number: 21089119
• Product Code: FOZ
• UDI-Device Identifier: 00382903835362
• UDI-Public: (01)00382903835362(10)5274628
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare 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: 5274628
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 03/16/2026
• 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