MAUDE Adverse Event Report: BECTON DICKINSON NEXIVA; INTRAVASCULAR CATHETER

Catalog Number	383641
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During use, the end cap does not seal properly with the cannula body, causing blood to leak.There are 10 defective units.Two defective products can be returned, and photographs are available.We require a claim settlement, a response to the complaint, and a receipt of the complaint.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
No photos or samples were received by our quality team for evaluation.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.The clear end cap, also known as the vent plug, was not connected or was blocked.As a result, leakage occurred and blood escaped from the control plug.Upon opening, the customer discovered that the vent plug had detached from the iv luer adapter.The cause of the loose vent plug was misalignment between the vent plug and the luer adapter during insertion.The design of the support gripper contributed to this issue.Corrective action was taken by modifying the gripper design to improve stability and ensure proper alignment of the luer adapter.The reported lot number was manufactured prior to the implementation of this corrective action.

• Brand Name: NEXIVA
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 25104162
• Report Number: 2243072-2026-00347
• Device Sequence Number: 15950321
• Product Code: FOZ
• UDI-Device Identifier: 00382903836413
• UDI-Public: (01)00382903836413(11)250514(17)280430(10)5130467
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Followup
• Report Date (Section B): 06/30/2026

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: 383641
• Device Lot Number: 5130467
• 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: 04/22/2026
• Supplement Date Received by Manufacturer: 05/27/2026; 06/30/2026
• Initial Report FDA Received Date: 05/06/2026
• Supplement Report FDA Received Date: 05/27/2026; 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown