MAUDE Adverse Event Report: BECTON DICKINSON NEXIVA 24GA 0.75IN Y W/ CAP; INTRAVASCULAR CATHETER

Catalog Number	383641
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd nexiva 24ga 0.75in y w/ cap.Leakage.We have received a complaint from our department regarding this product, specifically lot number 5085401.During use, it was observed that the product leaks.
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
Our quality engineer inspected the photos submitted for evaluation.The reported issue of package defective/ damaged was confirmed upon inspection of the photos.Based on the photo evaluation, it was observed that the bottom web pocket exhibited a curved formation.This issue likely occurred at the forming station during the pre-heating process.A probable cause is insufficient contact between the top and bottom web pre-heated plates during application.This lack of contact may be due to a jam on the pre-heated cylinder, which in turn could be caused by lubricant oxidation over time.Action was taken to revise the maintenance plan on 11 april 2025 to include inspection of the ¿pre-heat plate cylinder¿ and replacement if damage is found.The affected lot was built prior to this revision.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.

• Brand Name: NEXIVA 24GA 0.75IN Y W/ CAP
• 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: 23036890
• Report Number: 2243072-2025-01157
• Device Sequence Number: 18437057
• Product Code: FOZ
• UDI-Device Identifier: 00382903836413
• UDI-Public: (01)00382903836413(11)250402(17)280331(10)5085401
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 10/02/2025

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: 383641
• Device Lot Number: 5085401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/01/2025
• Supplement Date Received by Manufacturer: 10/02/2025
• Initial Report FDA Received Date: 09/12/2025
• Supplement Report FDA Received Date: 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown