MAUDE Adverse Event Report: BECTON DICKINSON NEXIVA MAXZERO; INTRAVASCULAR CATHETER

Catalog Number	383551
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2025
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 by customer that the clear end cap was not attached to the iv and was loose inside of the package.As a result, the iv has dripped blood out of the line after it is placed.Rcc received a complaint via email.Over the last week, we have had 5 instances of the 24g yellow bd nexia iv kits where the clear end cap was not attached to the iv and was loose inside of the package.As a result, the iv has dripped blood out of the line after it is placed.This has been seen by 4 different nurses when starting 24g ivs.Pt code: 4582.Device codes: 1250, 2912.Ref reports: mw5181269, mw5181270, mw5181271, mw5181272.
Additional Manufacturer Narrative
Our quality engineer inspected the photo submitted for evaluation.The reported issue of cap loose was confirmed upon inspection of the photo.However, bd cannot confirm the cause of the failure to our manufacturing process since no physical sample was returned.We would be very interested in examining product that does not meet your expectations and our quality standards.Examination of the actual product involved may provide clarification as to the cause of the reported failure.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.

• Brand Name: NEXIVA MAXZERO
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 24292644
• Report Number: 2243072-2026-00083
• Device Sequence Number: 9435873
• Product Code: FOZ
• UDI-Device Identifier: 00382903835515
• UDI-Public: (01)00382903835515(11)250520(17)280430(10)5136556
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2026

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: 383551
• Device Lot Number: 5136556
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2026
• Supplement Date Received by Manufacturer: 03/09/2026
• Initial Report FDA Received Date: 02/09/2026
• Supplement Report FDA Received Date: 03/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/20/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown