BD Nexiva™ Closed IV Catheter System with NearPort™ IV Access 393522Recalls & reported problems
Becton, Dickinson And Company · NEXIVA NEARPORT 22GA X 1.00IN W/ MAXZERO · Class 2
All models of BD Nexiva Closed IV Catheter System with NearPort IV Access (5)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00382903935222), received between Aug 14, 2025 and Jul 8, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Defective Component1
- Leak/Splash1
- Material Integrity Problem1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionJul 8, 2026Product Quality Problem
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25749521 ↗MalfunctionJan 26, 2026Break
IT WAS REPORTED THAT BD NEXIVA NEARPORT 22GA X 1.00IN W/ MAXZERO CATHETER BROKE / SEPARATED AFTER PLACEMENT. IT WAS REPORTED BY CUSTOMER THAT THE NEXIVA NEARPORT 22G X 1¿ IV CATHETER TUBING BROKE OFF. LOCATION OF THE BREAK WAS AT THE EXTENSION SET AND THE CATHETER HUB. RCC RECEIVED A COMPLAINT VIA EMAIL. PLEASE ACCEPT THIS EMAIL AS NOTIFICATION OF THE FOLLOWING COMPLAINT. XXX. DATE OF INCIDENT: (B)(6) 2026. PRODUCT CODE: 393522. LOT #: UNKNOWN. DESCRIPTION OF INCIDENT: NEXIVA NEARPORT 22G X 1¿ IV CATHETER TUBING BROKE OFF. LOCATION OF THE BREAK WAS AT THE EXTENSION SET AND THE CATHETER HUB. THERE WAS NO PATIENT HARM HOWEVER THE DEVICE WAS INDWELLING AT THE TIME OF THE FRACTURE, AND THE LINE HAD TO BE REMOVED. PHOTOS ARE ATTACHED TO THIS EMAIL, AND THE CUSTOMER RETAINED THE DEVICE AND IS WILLING TO SEND TO BD FOR EVALUATION. CUSTOMER IS COPIED ON THIS EMAIL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24178187 ↗MalfunctionAug 14, 2025Leak/Splash; Defective Component; Material Integrity Problem; Leak/Splash; Defective Component; Material Integrity Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22812239 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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