addEASE® N7995Recalls & reported problems
B. Braun Medical Inc. · addEASE® Binary Connector with 17 Ga. Needle · Class 2
- 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 04046964187018), received between Feb 18, 2020 and Sep 19, 2025 — classified as 3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Contamination /Decontamination Problem2
- Device Misassembled During Manufacturing /Shipping1
Patient problems
- No Clinical Signs, Symptoms or Conditions2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 19, 2025Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: DETAILED INQUIRY DESCRIPTION: ONE OF THE NURSES REPORTED THAT THEY NOTICED WHAT APPEARED TO BE A PLASTIC PIECE AT THE BOTTOM OF THE VIAL WHEN THE ADDEASE (WHITE TOP, ITEM REF. N7995) WAS UTILIZED. NO INJURY REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23097486 ↗MalfunctionOct 15, 2024Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping
AS REPORTED, OUR WHITE ADDEASE CONNECTORS, N7995 HAVE A SHORT NEEDLE AGAIN AND ARE UNABLE TO ATTACH TO 250ML BAG PROPERLY. UPON REVIEWING THE CONNECTORS IN THE BAG LOT 0061937209, WE ALSO NOTICED ONE OF THE CONNECTORS HAS WHITE POWDER AND SEEMED TO BE USED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20456679 ↗MalfunctionFeb 18, 2020Contamination /Decontamination Problem; Contamination /Decontamination Problem
AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT INK WAS NOTED ON THE VIAL SPIKE. NO INJURY REPORTED.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 9720668 ↗
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- 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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.