addEASE® BC2000Recalls & reported problems
B. Braun Medical Inc. · addEASE® BC2000 Binary Connector · Class 2
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964186592), received between May 5, 2025 and Feb 4, 2026 — classified as 3 malfunctions.
The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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
- Contamination /Decontamination Problem3
- Device-Device Incompatibility1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2026Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: GREEN ADDEASE CONNECTOR HAS THE WHITE PELLET STUCK INSIDE THE FLUID MIXING CHAMBER. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24257773 ↗MalfunctionDec 30, 2025Contamination /Decontamination Problem; Device-Device Incompatibility; Contamination /Decontamination Problem; Device-Device Incompatibility
ACCORDING TO THE COMPLAINANT: ON THE RIGHT SIDE OF THE PLUG THERE IS ALSO A GRAY ELEMENT THAT WAS ATTACHED TO IT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23927467 ↗MalfunctionMay 5, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: BRIEF INQUIRY DESCRIPTION: BLACK PARTICLE FOUND IN ADDEASE ASSEMBLY. DETAILED INQUIRY DESCRIPTION: RN WHEN TO ACTIVATE ADDEASE ASSEMBLY BUT FOUND A BLACK SPECK ON THE WHITE RUBBER PLUG FROM THE ADDEASE. THE BLACK SPECK DID NOT COME OFF THE WHITE RUBBER PLUG, BUT WHEN I SHOOK THE ASSEMBLY, IT THEN REMOVED ITSELF FROM THE WHITE PLUG. THE BLACK SPECK IS STILL IN THE ASSEMBLY UNIT, BUT IT'S NO LONGER VISIBLE. IT IS STUCK SOMEWHERE IN THE SYSTEM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21961383 ↗
Other Set, i.V. Fluid transfer devices
- EXACTAMIX H938740Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,350 reports
- EXACTAMIX H938738Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall1,180 reports
- EXACTAMIX H938739Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall972 reports
- EXACTAMIX H938741Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall710 reports
- EXACTAMIX H938737Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall607 reports
- EXACTAMIX H938724Baxter Healthcare Corporation · Set, i.V. Fluid transfer1 recall513 reports
- EXACTAMIX H938173Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls260 reports
- EXACTAMIX H938176Baxter Healthcare Corporation · Set, i.V. Fluid transfer2 recalls232 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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