MAUDE Adverse Event Report: BECTON DICKINSON NEXIVA 24 GA X 3/4 IN SINGLE PORT; INTRAVASCULAR CATHETER

Catalog Number	383511
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/28/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
This is a complaint about foreign-body adhesion before use.It was reported that black, residue-like material adhering to the catheter portion before use.
Additional Manufacturer Narrative
Our quality engineer inspected the photos and sample submitted for evaluation.The reported issue of foreign matter was confirmed upon inspection of the sample.Analysis of the sample showed black sticky material on the catheter tubing.The sample was sent for microscope fourier transform infrared spectroscopy to determine the foreign material type.The results showed the spectrum of foreign matter matched with silicone material.Silicone material is used as lubricant on the catheter adapter.The foreign matter was likely dropped on the catheter assembly during the silicone lubricant process.Action was taken to communicate the defect with the production technician and housekeeping was conducted to ensure the line was cleaned.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records have been reviewed, and this batch meets our manufacturing specification requirements.

• Brand Name: NEXIVA 24 GA X 3/4 IN SINGLE PORT
• 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
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 23466645
• Report Number: 2243072-2025-01353
• Device Sequence Number: 10089450
• Product Code: FOZ
• UDI-Device Identifier: 00382903835119
• UDI-Public: (01)00382903835119(11)250319(17)280229(10)5075190
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2026

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: 383511
• Device Lot Number: 5075190
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 01/05/2026
• Initial Report FDA Received Date: 11/04/2025
• Supplement Report FDA Received Date: 01/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/19/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown