Extension Set V6223Recalls & reported problems
B. Braun Medical Inc. · Microbore Extension Set with Female Luer Lock Connector, Spin-Lock® Connector, and PE FluidPath Tubing · Class 2
All models of Extension Set (41)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046964189234), received between Mar 21, 2024 and Aug 5, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Leak/Splash” (3 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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Leak/Splash3
- Contamination /Decontamination Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionAug 5, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 2: BRIEF INQUIRY DESCRIPTION, BACKFLOW OF BLOOD & MEDICATION INTO TUBING AND SYRINGE. DETAILED INQUIRY DESCRIPTION TWO INSTANCES OF LEAKAGE AND BACKFLOW INTO BD SYRINGE DURING INFUSION. SETUP INVOLVES A PERFUSOR, B. BRAUN TUBING (V6223), BD 10ML SYRINGE & HEMODIALYSIS MACHINE. LEAKAGE OCCURRED AT B. BRAUN TUBING CONNECTION TO BD 10ML LUER LOCK. FIRST INCIDENT INVOLVED IRON SUCROSE INFUSION, SECOND INCIDENT INVOLVED FERROC GLUCONATE INFUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22713455 ↗MalfunctionAug 5, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: EVENT 1: BRIEF INQUIRY DESCRIPTION BACKFLOW OF BLOOD & MEDICATION INTO TUBING AND SYRINGE. DETAILED INQUIRY DESCRIPTION TWO INSTANCES OF LEAKAGE AND BACKFLOW INTO BD SYRINGE DURING INFUSION. SETUP INVOLVES A PERFUSOR, B. BRAUN TUBING (V6223), BD 10ML SYRINGE & HEMODIALYSIS MACHINE. LEAKAGE OCCURRED AT B. BRAUN TUBING CONNECTION TO BD 10ML LUER LOCK. FIRST INCIDENT INVOLVED IRON SUCROSE INFUSION, SECOND INCIDENT INVOLVED FERROC GLUCONATE INFUSION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22713454 ↗MalfunctionJan 30, 2025Leak/Splash; Leak/Splash
PER UF/IMPORTER REPORT # (B)(4): DESCRIBE THE EVENT OR PROBLEM: MICROBORE EXTENSION SET LEAKING AT GREEN HUB WHILE INFUSING DOPAMINE. PATIENT EXPERIENCED DECREASED ARTERIAL PRESSURE. PATIENT REQUIRED NORMAL SALINE BOLUS, INCREASED DOPAMINE AND INCREASED EPINEPHRINE FOLLOWING THIS ISSUE. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? MEDICATION INFUSION WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING) THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: CARDIAC DRUGS. OTHER INFORMATION ABOUT THE PATIENT THAT MAY HAVE INFLUENCED THE OUTCOME OF THE EVENT: NONE OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: PREEXISTING CHARACTERISTICS THAT MAY HAVE CONTRIBUTED TO THE EVENT: HYPERTENSION.
Patient problems: Low Blood Pressure/ Hypotension
MAUDE report 21272905 ↗MalfunctionMar 21, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE SUER FACILITY: DETAILS OF COMPLAINT (REPORTED ISSUE): TUBING THAT WAS DEFECTIVE WAS SAVED AS WAS THE MEDICATION THAT WAS BEING FLUSHED THROUGH THE TUBING WHEN THE MILKY SUBSTANCE WAS NOTED. THE MEDICATION WAS CLEAR, SO IT APPEARED THE ISSUE WAS WITH THE TUBING. NEW TUBING AND MEDICATION WERE USED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18948293 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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