BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ 383597Recalls & reported problems
Becton, Dickinson And Company · NEXIVA DIFFUSICS w/MaxZero 20G X 1.00 IN · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00382903835973), received between Apr 6, 2026 and May 15, 2026 — classified as 2 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
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 15, 2026Break
IT WAS REPORTED BY CUSTOMER THAT THE DEFECTIVE DIFFUSUS THAT SPLIT IN HALF. VERBATIM: DEACONESS ED EXPERIENCED A DEFECTIVE DIFFUSICS THAT SPLIT IN HALF. CAN YOU PLEASE WORK DIRECTLY WITH HALEY TO HAVE A RETURN LABEL AND BOX MAILED TO THEM AS THEY KEPT THE ITEM. EVENT OCCURRED ON 4/28/26, NEAR MISS, NO HARM. RN (B)(6) APPROACHED THIS WRITER WHO WAS WORKING AS CHARGE ON (B)(6) 2026. RN ERIN ATTEMPTED TO START AN IV ON PATIENT, AND THE END OF THE EXTENSION WHERE THE FLOW RATE ATTACHMENT MEETS THE TUBING, BROKE OFF SUDDENLY."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 25185801 ↗MalfunctionApr 6, 2026Leak/Splash; Manufacturing, Packaging or Shipping Problem
IT WAS REPORTED BY THE CUSTOMER THAT THEY FOUND SEVERAL KITS THAT HAD THE ONE WAY VALVE DISLODGED. VERBATIM: I FOUND SEVERAL KITS THAT HAD THE ONE WAY VALVE DISLODGED. THERE HAS BEEN AN INCREASE IN OCCURRENCES WHERE THE BLOOD COMES RIGHT OUT SINCE THE VALVE WAS NOT ATTACHED TO THE LINE. TO HELP MITIGATE THIS, I HAVE RELAYED THIS CONCERN TO THE BD REPS AND THE ICTS AND RNS ARE MORE INCLINED TO CHECK EACH KIT BEFORE INSERTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24790430 ↗
Other Catheter, intravascular, therapeutic, short-term less than 30 days devices
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- 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.
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