Extension Set V6222Recalls & reported problems
B. Braun Medical Inc. · MICRBR EXT W/ PVC FREE FLD PATH, 60 IN. · 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 04046964189210), received between Dec 10, 2018 and Dec 4, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 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
- Contamination /Decontamination Problem2
- Fluid/Blood Leak1
- Leak/Splash1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Blood Loss1
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionDec 4, 2025Leak/Splash; Leak/Splash
AS REPORTED BY THE USER FACILITY: REASON OF COMPLAINT: RN ABOUT TO CHECK FOR BLOOD RETURN (FOR CHEMO INFUSION) FROM LOWER PORT WHERE SYRINGE LINE SCREWS IN. NOTED THAT THE INNER TUBING HAD CRACKED. OTHER RN DESCRIBED THE INNER TUBING AS "EATING INTO THE RUBBER OF THE PORT". PLEASE NOTE BLOOD IN THE LINE OCCURRED WHEN IV FLUIDS WERE STOPPED - NO PRESSURE FROM IV FLUID CAUSED BLOOD TO BACKFLOW.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23714986 ↗MalfunctionMar 18, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 2, BRIEF INQUIRY DESCRIPTION: OPEN INFUSION PORTS/SPOTS ON INJECTION PORT. DETAILED INQUIRY DESCRIPTION: 18 TWISTS OFF PORTS (INFUSION PORTS OPEN AT SEAL), 2 VISUALS (BLACK/BROWN SPECKS ON INJECTION PORT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21631025 ↗MalfunctionMar 18, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: EVENT 1 BRIEF INQUIRY DESCRIPTION OPEN INFUSION PORTS/SPOTS ON INJECTION PORT DETAILED INQUIRY DESCRIPTION 18 TWIST OFF PORTS(INFUSION PORTS OPEN AT SEAL) 2 VISUALS (BLACK/BROWN SPECKS ON INJECTION PORT).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21631021 ↗MalfunctionDec 10, 2018Fluid/Blood Leak; Fluid/Blood Leak
AS REPORTED BY THE USER FACILITY: DURING USE THE EXTENSION SET LEAKED BLOOD. NO INJURY REPORTED.
Patient problems: Blood Loss
MAUDE report 8148466 ↗
Other Set, administration, intravascular devices
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- Medtronic Extended MMT-431AUnomedical A/S · Set, Administration, Intravascular3 deaths8,574 reports
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- CADD 21-7302-24Icu Medical, Inc. · Set, administration, intravascular4 recalls1 death4,657 reports
- Autosoft XC 1001681Unomedical A/S · Set, Administration, Intravascular1 death4,216 reports
- Minimed™ Quick-set™ MMT-397AUnomedical A/S · Set, Administration, Intravascular19 deaths4,134 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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