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

Catalog Number	383551
Medical Device Problem Code	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
Our quality engineer inspected the photo submitted for evaluation.The reported issues of cap loose and leakage were confirmed upon inspection of the photo.The clear end cap, also known as the vent plug, was not connected or was blocked by the vent plug or the bd max zero.As a result, leakage occurred and blood escaped from the control plug.The root cause of the loose vent plug is 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 was manufactured prior to the implementation of this corrective action.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.
Event or Problem Description
It was reported by the customer that 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.Verbatim: rcc received a complaint via email.Email(s) attached.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.Mw5181269, mw5181271, mw5181272, mw5181273.
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

• 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 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: 24279279
• Report Number: 2243072-2026-00079
• Device Sequence Number: 21297678
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2026

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: 383551
• Device Lot Number: 5136556
• 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: 01/23/2026
• Supplement Date Received by Manufacturer: 03/05/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 03/09/2026
• 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