BD Nexiva™ Diffusics™ Closed IV Catheter System 383596Recalls & reported problems
Becton, Dickinson And Company · NEXIVA DIFFUSICS w/MaxZero 22G X 1.00 IN · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This BD Nexiva Diffusics closed IV catheter is a short-term intravenous line placed for patients needing IV therapy or fluids. Reports mostly describe the catheter leaking, with26 mentioning leaking or splashing, plus a missing vent plug, a hole in the material, and a safety needle shield that would not activate so the needle could not be removed. There are 27 reports, with no deaths and no injuries, and no recalls name this device. Reports jumped from 1 in the prior 12 months to 25 in the last 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 27
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 00382903835966), received between Aug 20, 2024 and Apr 24, 2026 — classified as 27 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (26 reports).
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
- Leak/Splash26
- Activation Problem1
- Manufacturing, Packaging or Shipping Problem1
- Material Puncture/Hole1
Patient problems
- No Clinical Signs, Symptoms or Conditions27
Recent adverse event reports
The 25 most recent of 27 reports, in the reporter's own words as published by the FDA.
MalfunctionApr 24, 2026Leak/Splash
IT WAS REPORTED BY CUSTOMER THAT CATHETER HAS LEAK. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED CATHETER HAS LEAK.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24984231 ↗MalfunctionApr 3, 2026Leak/Splash; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED BY A CUSTOMER THAT THE CLEAR PLASTIC CAP (VENT PLUG) IS EITHER DISCONNECTED OR MISSING FROM THE PACKAGING AND RESULTED IN A LOT OF BLOOD LEAKAGE AND EXPOSURE DURING USE. THE CLEAR PLASTIC CAP (VENT PLUG) IS EITHER DISCONNECTED OR MISSING FROM THE PACKAGING. THE AFFECTED LOT NUMBER IS 5338239. I¿VE ATTACHED A FEW PHOTOS FOR YOUR REFERENCE. THIS ISSUE HAS, IN SOME CASES, RESULTED IN A LOT OF BLOOD LEAKAGE AND EXPOSURE DURING USE, WHICH IS OBVIOUSLY A CONCERN.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24781044 ↗MalfunctionJan 22, 2026Activation Problem
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS W/MAXZERO 22G X 1.00 IN SAFETY SHIELD ACTIVATION FAILED IT WAS REPORTED BY THE CUSTOMER THAT WAS TRYING TO SAFETY THE NEEDLE AFTER PLACING THE IV. THE CUSTOMER HEARD THE CLICK OF THE SAFETY FEATURES ACTIVATING AND THE NEEDLE LOCKING. WHEN TRYING TO REMOVE THE NEEDLE FROM THE CATHETER BY PULLING ON THE WHITE HE COULD NOT REMOVE THE NEEDLE DESPITE THE NEEDLE BEING LOCKED AND HE WAS NOT HOLDING THE GREY IN PLACE WITH THE CATHETER. THE CUSTOMER IS VERY FAMILIAR WITH THESE CATHETERS, AND IT HAPPENED 3 TIMES WITH THE 22G DFFX. CUSTOMER WAS TRYING TO SAFETY THE NEEDLE AFTER PLACING THE IV. THE CUSTOMER HEARD THE CLICK OF THE SAFETY FEATURES ACTIVATING AND THE NEEDLE LOCKING. WHEN TRYING TO REMOVE THE NEEDLE FROM THE CATHETER BY PULLING ON THE WHITE HE COULD NOT REMOVE THE NEEDLE DESPITE THE NEEDLE BEING LOCKED AND HE WAS NOT HOLDING THE GREY IN PLACE WITH THE CATHETER. THE CUSTOMER IS VERY FAMILIAR WITH THESE CATHETERS, AND IT HAPPENED 3 TIMES WITH THE 22G DFFX. 383596, 5189322.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24146447 ↗MalfunctionJan 16, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24094607 ↗MalfunctionJan 16, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093808 ↗MalfunctionJan 16, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093805 ↗MalfunctionJan 16, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093803 ↗MalfunctionJan 16, 2026Leak/Splash
NO ADDITIONAL INFORMATION
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093802 ↗MalfunctionJan 16, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093801 ↗MalfunctionJan 16, 2026Leak/Splash
LEAKING HAPPENING WHILE FLUSHING AT THE CONNECTION OF NEXIVA HUB AND MAXZERO. A FEW DROPLETS OF SALINE LEAK OUT. POTENTIAL EXPOSURE TO BLOOD ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? NO ADVERSE EVENT OR SERIOUS INJURY TO PATIENT OR HEALTHCARE WORKER. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT 29-12-2025?
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093796 ↗MalfunctionJan 16, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093528 ↗MalfunctionJan 16, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24093527 ↗MalfunctionJan 12, 2026Leak/Splash
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS W/MAXZERO 22G X 1.00 IN LEAKED IT WAS REPORTED BY CUSTOMER THAT THE LEAKING OBSERVED AT CONNECTION OF MAXZERO AND DIFFUSICS. VERBATIM: LEAKING OBSERVED AT CONNECTION OF MAXZERO AND DIFFUSICS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24047010 ↗MalfunctionJan 12, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24047008 ↗MalfunctionJan 12, 2026Leak/Splash
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS W/MAXZERO 22G X 1.00 IN LEAKED. IT WAS REPORTED BY CUSTOMER THAT THE LEAKING OBSERVED AT CONNECTION OF MAXZERO AND DIFFUSICS. LEAKING OBSERVED AT CONNECTION OF MAXZERO AND DIFFUSICS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24047005 ↗MalfunctionJan 12, 2026Leak/Splash
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS W/MAXZERO 22G X 1.00 IN LEAKED IT WAS REPORTED BY CUSTOMER THAT THE LEAKING OBSERVED AT CONNECTION OF MAXZERO AND DIFFUSICS VERBATIM: LEAKING OBSERVED AT CONNECTION OF MAXZERO AND DIFFUSICS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24047003 ↗MalfunctionJan 12, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24047001 ↗MalfunctionJan 9, 2026Leak/Splash
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS W/MAXZERO 22G X 1.00 IN LEAKED IT WAS REPORTED BY CUSTOMER THAT "LEAKING OBSERVED AT CONNECTION OF MAXZERO AND DIFFUSICS" VERBATIM: LEAKING OBSERVED AT CONNECTION OF MAXZERO AND DIFFUSICS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24022358 ↗MalfunctionJan 8, 2026Leak/Splash
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS W/MAXZERO 22G X 1.00 IN LEAKED IT WAS REPORTED BY CUSTOMER THAT "LEAKING OBSERVED AT CONNECTION OF MAXZERO AND DIFFUSICS." LEAKING OBSERVED AT CONNECTION OF MAXZERO AND DIFFUSICS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24005754 ↗MalfunctionJan 8, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24005265 ↗MalfunctionJan 8, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24004867 ↗MalfunctionJan 2, 2026Leak/Splash
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS W/MAXZERO 22G X 1.00 IN LEAKED IT WAS REPORTED BY CUSTOMER THAT LEAKING AT CONNECTION POINT BETWEEN MAX ZERO CONNECTOR AND DIFFUSICS HUB. LEAKING AT CONNECTION POINT BETWEEN MAX ZERO CONNECTOR AND DIFFUSICS HUB.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23945105 ↗MalfunctionJan 2, 2026Leak/Splash
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS W/MAXZERO 22G X 1.00 IN LEAKED IT WAS REPORTED BY CUSTOMER THAT LEAKING AT CONNECTION OF MAXZERO TO HUB OF DIFFUSICS. SMALL LEAKAGE/MOVEMENT OF FLUIDS OUT OF THE THREADS AND ONTO PATIENT OR HCP. MAINLY ON FLUSHING. LEAKING AT CONNECTION OF MAXZERO TO HUB OF DIFFUSICS. SMALL LEAKAGE/MOVEMENT OF FLUIDS OUT OF THE THREADS AND ONTO PATIENT OR HCP. MAINLY ON FLUSHING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23944616 ↗MalfunctionJan 2, 2026Leak/Splash
IT WAS REPORTED THAT BD NEXIVA DIFFUSICS W/MAXZERO 22G X 1.00 IN LEAKED IT WAS REPORTED BY CUSTOMER THAT LEAKING OBSERVED AT CONNECTION BETWEEN MAXZERO HUB AND DIFFUSICS PORT. LEAKING OBSERVED AT CONNECTION BETWEEN MAXZERO HUB AND DIFFUSICS PORT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23944613 ↗MalfunctionJan 2, 2026Leak/Splash
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23944228 ↗
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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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