BD Nexiva™ Diffusics™ Closed IV Catheter System with BD MaxZero™ 383587Recalls & reported problems
Becton, Dickinson And Company · NEXIVA DIFFUSICS w/MaxZero 20G X 1.25 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 00382903835874), received between Feb 26, 2026 and Feb 26, 2026 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (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
- Air/Gas in Device1
- Leak/Splash1
- Material Integrity 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.
MalfunctionFeb 26, 2026Leak/Splash; Air/Gas in Device
IT WAS REPORTED BY A CUSTOMER THAT A CATHETER HAD THE END PIECE FALL OFF BEFORE BEING USED ON THE PATIENT AND THE SECOND INCIDENT WHERE THE BLOOD LEAKED OUT FROM THE SAME CONNECTION ON THE CLOSED-SYSTEM TUBING. VERBATIM: "I WANTED TO SHARE WITH YOU THESE PICTURES AND DETAILS OF TWO SITUATIONS WHERE PROBLEMS WERE OBSERVED WITH 20 GA X 1.25" NEXIVA CATHETERS. ONE SET OF PICTURES IS FROM (B)(6) 2026 WHERE A CATHETER HAD THE END PIECE FALL OFF BEFORE BEING USED ON THE PATIENT. I TOOK THE PICTURE AND KEPT IT IN CASE THIS TURNED OUT TO BE MORE THAN A ONE-OFF FLUKE. TODAY (B)(6) 2026 I PLACED THE CATHETER IN THE SECOND SET OF PICTURES AND BLOOD LEAKED OUT FROM THE SAME CONNECTION ON THE CLOSED-SYSTEM TUBING. WE TRIED TO SALVAGE THIS IV BUT HAD TO DISCONTINUE DUE TO THIS LEAK. AIR WAS BEING SUCKED IN WHEN TRYING TO DRAW BLOOD. WE DID NOT ATTEMPT TO FLUSH THE IV. THE LOT NUMBERS ARE VISIBLE IN THE PICTURES. PLEASE LET ME KNOW WHAT WE CAN DO TO HELP! IS THIS A PROBLEM Y'ALL HAVE GOTTEN FEEDBACK ON YET? THANK YOU!"
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24457030 ↗MalfunctionFeb 26, 2026Material Integrity Problem
NO ADDITIONAL INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24457027 ↗
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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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