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	01/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by customer that twice in one day a 24 gauge iv was used to insert a piv on a patient and both times the clear cap was missing at the end so there was no backflow stop and the blood ended up dripping out of the end.Verbatim: rcc received a complaint via email.Email(s) attached.Product problem report product information product code: 383511 product description: catheter iv closed nexiva 24g x & 0.75in w/single port bx/20 lot/serial #: (b)(6) expiry date: unknown problem information product concern ticket number: (b)(4) date of incident: (b)(6) 2026 concern description: twice in one day a 24 gauge iv was used to insert a piv on a patient and both times the clear cap was missing at the end so there was no backflow stop and the blood ended up dripping out of the end.Occurrences: 1 each reporter information site information sample information incident samples: 0 representative samples: 0 no adverse event reported additional information: what was the impact to the patient? pt bled slightly more than usual with insertion, minimal impact.If possible, could you please provide picture samples for investigation? unfortunately, no pictures.
Additional Manufacturer Narrative
H3: if a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
No photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.

• 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: 24304955
• Report Number: 2243072-2026-00091
• Device Sequence Number: 20162271
• Product Code: FOZ
• UDI-Device Identifier: 00382903835515
• UDI-Public: (01)00382903835515(11)250520(17)280430(10)5136556
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K183399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2026

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: 01/28/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 02/10/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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