BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ 383599Recalls & reported problems
Becton, Dickinson And Company · NEXIVA DIFFUSICS w/MaxZero 20G X 1.75 IN · Class 2
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 00382903835997), received between Sep 24, 2024 and Apr 15, 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
- Leak/Splash1
- Material Integrity Problem1
- Nonstandard Device1
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.
MalfunctionApr 15, 2026Nonstandard Device; Material Integrity Problem
IT WAS REPORTED BY THE CUSTOMER THAT PIECE OF THE FLOW RATE INDICATOR ON THE END OF THE LINE FELL OFF. VERBATIM: NURSE REPORTED PIECE OF THE FLOW RATE INDICATOR ON THE END OF THE LINE FELL OFF. SEE PICTURES FOR DETAILS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24887945 ↗MalfunctionJun 17, 2025Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS W/MAXZERO 20G X 1.75 IN LEAKED IT WAS REPORTED BY CUSTOMER THAT THE LEAKING AT THE HUB BEFORE EXTENSION SET VERBATIM: LEAKING AT THE HUB BEFORE EXTENSION SET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22236031 ↗MalfunctionSep 24, 2024Break; Break
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS W/MAXZERO 20G X 1.75 IN TUBING SEPERATED. IT WAS REPORTED BY CUSTOMER THAT THE NEXIVA 20G DIFFUSIC THAT FELL APART WHILE ATTEMPTING TO INSERT. THE DEVICE FAILED AFTER IT WAS IN THE PATIENT¿S ARM, AND THEY NEEDED TO BE STUCK AGAIN. VERBATIM: I HAVE ATTACHED A PHOTO OF A NEXIVA 20G DIFFUSIC THAT FELL APART WHILE ATTEMPTING TO INSERT. THE DEVICE FAILED AFTER IT WAS IN THE PATIENT¿S ARM, AND THEY NEEDED TO BE STUCK AGAIN. CHARLIE WAS THE NURSE THAT HIS HAPPENED TO. HE SAYS HE WAS INSERTION LIKE NORMAL. NO UNUSUAL CIRCUMSTANCES. I HAVE THE ITEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20296046 ↗
Other Catheter, intravascular, therapeutic, short-term less than 30 days devices
- BD Insyte Autoguard 382523Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days660 reports
- BD Insyte Autoguard 382533Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls527 reports
- BD PosiFlush 306546Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 death608 reports
- BD Insyte Autoguard Shielded IV Catheter 381823Becton, Dickinson And Company · Catheter, intravascular, therapeutic, short-term less than 30 days582 reports
- BD Insyte Autoguard 381423Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall528 reports
- BD Insyte Autoguard 382544Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall437 reports
- BD Nexiva, BD Q-Syte 383536Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls374 reports
- BD PosiFlush 306547Becton, Dickinson And Company · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 death331 reports
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.
How reports and recalls are matched · Editorial policy · Report an error on this page