BD Nexiva™ Closed IV Catheter System 383642Recalls & reported problems
Becton, Dickinson And Company · BD Nexiva™ Closed IV Catheter System 22GA x 1.00IN · Class 2
All models of BD Nexiva Closed IV Catheter System (7)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 10
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00382903836420), received between Nov 26, 2024 and Sep 25, 2026 — classified as 10 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (4 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/Splash4
- Break3
- Appropriate Device Problem Term/Code Not Available2
- Material Split, Cut or Torn2
- Defective Component1
- Product Quality Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
Recent adverse event reports
The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 25, 2026Leak/Splash
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50902634 ↗MalfunctionMar 30, 2026Leak/Splash
NO NEW INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24736822 ↗MalfunctionFeb 6, 2026Leak/Splash; Product Quality Problem
IT WAS REPORTED THAT THE CAP OF THE RESERVE VALVE (ON THE SIDE) KEEPS FALLING OFF SPONTANEOUSLY. THIS CAUSES BLOOD TO RUN OUT RESPONSE RECEIVED ON: 2/5/2026. WAS PATIENT OR USER HARMED? À NO.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24281766 ↗MalfunctionJan 9, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT BD NEXIVA 22GA 1.00IN Y W/ CAP CATHETER BROKE / SEPARATED AFTER PLACEMENT CATHETER HAS SPLIT OFF OF THE SIDE OF THE STYLET AS IT ENTERED THE VEIN- ELICITING PAIN. USER REMOVED CATHETER FROM PACKAGING, ENSURED THAT THE STYLET AND CATHETER MOVED EASILY- CATHETER APPEARED SAFE TO USE. CANNULATION WAS STRAIGHTFORWARD UNTIL PAIN ELICITED. REMOVED AND ENSURED PT WAS SAFE. REMOVED CATHETER- FOUND THAT THE CATHETER WAS SPLIT AWAY FROM THE STYLET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24022370 ↗MalfunctionJan 9, 2026Material Split, Cut or Torn
IT WAS REPORTED THAT BD NEXIVA 22GA 1.00IN Y W/ CAP CATHETER BROKE / SEPARATED AFTER PLACEMENT CATHETER HAS SPLIT OFF OF THE SIDE OF THE STYLET AS IT ENTERED THE VEIN- ELICITING PAIN. USER REMOVED CATHETER FROM PACKAGING, ENSURED THAT THE STYLET AND CATHETER MOVED EASILY- CATHETER APPEARED SAFE TO USE. * CANNULATION WAS STRAIGHTFORWARD UNTIL PAIN ELICITED. * REMOVED AND ENSURED PT WAS SAFE. REMOVED CATHETER- FOUND THAT THE CATHETER WAS SPLIT AWAY FROM THE STYLET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24022366 ↗MalfunctionJan 3, 2026Break
CATHETER HAS SPLIT OFF OF THE SIDE OF THE STYLET AS IT ENTERED THE VEIN- ELICITING PAIN. USER REMOVED CATHETER FROM PACKAGING, ENSURED THAT THE STYLET AND CATHETER MOVED EASILY- CATHETER APPEARED SAFE TO USE. CANNULATION WAS STRAIGHTFORWARD UNTIL PAIN ELICITED. REMOVED AND ENSURED PT WAS SAFE. REMOVED CATHETER- FOUND THAT THE CATHETER WAS SPLIT AWAY FROM THE STYLET.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23952995 ↗MalfunctionJan 3, 2026Break; Appropriate Device Problem Term/Code Not Available
NO ADDITIONAL INFORMATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 23952994 ↗MalfunctionJan 3, 2026Break; Appropriate Device Problem Term/Code Not Available
NO ADDITIONAL INFORMATION.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; No Clinical Signs, Symptoms or Conditions
MAUDE report 23952993 ↗MalfunctionJul 17, 2025Defective Component; Defective Component
IT WAS REPORTED THAT BD NEXIVA 22GA 1.00IN Y W/ CAP HAD PLASTIC PART AROUND THE NEEDLE IS DEFECTIVE WE HEREBY INFORM YOU OF A COMPLAINT ABOUT THE PRODUCT QUALITY, WITH THE INTERNAL COMPLAINT NUMBER (B)(4) OF THE ARTICLE 1X 4813444, BD NEXIVA KATH SYST 22G 0.9X25MM Y-VER BLUE 20 PCS. DEFECT REPORTED BY THE CUSTOMER: PLASTIC PART AROUND THE NEEDLE IS DEFECTIVE. THE PLASTIC SHOULD REMAIN IN THE VEIN AS SOON AS THE NEEDLE IS PULLED OUT. THIS DOES NOT WORK. IF YOU THEN PULL OUT THE NEEDLE INCLUDING PLASTIC, YOU CAN SEE A SLIT ON PLASTIC. WHEN DID THE INCIDENT OCCUR? DURING USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22531916 ↗MalfunctionNov 26, 2024Leak/Splash; Leak/Splash
IT WAS REPORTED THAT BD NEXIVA 22GA 1.00IN Y W/ CAP LEAKAGE AT SEPTUM FILTER IS LOOSE IN THE PACKAGING BEFORE USE DESCRIPTION OF COMPLAINT FILTER IS LOOSE IN PACKAGING. AS A RESULT IN 3 PATIENTS WHEN INSERTING IV NEEDLE, BLOOD RAN BACK (TAMPERING). NO CONSEQUENCES FOR THE PATIENTS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20789128 ↗
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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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