MAUDE Adverse Event Report: BECTON DICKINSON NEXIVA; INTRAVASCULAR CATHETER

Catalog Number	383531
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2025
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
It was reported that bd nexiva 24ga 0.75in y had foreign matter red substance found in cannula prior to insertion before use red substance noticed in cannula 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 foreign matter on the wing adapter.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.The foreign matter was traced to damage on the isolated gate cap located at the nozzle tip of the second-shot mold.When this gate cap is compromised, fragments of the damaged material can mix with the melted resin during injection.These fragments are then carried into the mold cavity, where they become embedded in the final molded part.Due to the differences in color and material properties between the fragments and the resin, the defect becomes noticeable.To prevent this defect, replacement of the isolated gate cap will be added to the biannual preventive maintenance.

• 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: 22666202
• Report Number: 2243072-2025-00939
• Device Sequence Number: 7440125
• Product Code: FOZ
• UDI-Device Identifier: 00382903835317
• UDI-Public: (01)00382903835317(11)241208(17)271130(10)4341672
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 09/16/2025

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: 383531
• Device Lot Number: 4341672
• 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: 07/11/2025
• Supplement Date Received by Manufacturer: 09/16/2025
• Initial Report FDA Received Date: 07/30/2025
• Supplement Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown