SPIKE ADAPTER 418105Recalls & reported problems
B. Braun Medical Inc. · Vented Spike Adaptor · Class 2
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04022495843593), received between Dec 8, 2022 and Oct 30, 2024 — classified as 2 malfunctions.
The most frequently reported specific device problem is “Air/Gas in Device” (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
- Air/Gas in Device2
Patient problems
- No Clinical Signs, Symptoms or Conditions2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionOct 30, 2024Air/Gas in Device; Air/Gas in Device
AS REPORTED BY USER FACILITY: WE HAD SEVERAL ISSUED USING YOUR VENTED SPIKE CONNECTOR WITH INVOLVED THE SECONDARY LINE RUNNING DRY DESPITE THERE STILL BEING FLUID IN THE GLASS BOTTLE. THE PUMP PULLED FROM THE PRIMARY LINE AND RAN IT DRY, LEAVING THE GLASS BOTTLE STILL FULL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20571115 ↗MalfunctionDec 8, 2022Air/Gas in Device; Air/Gas in Device
AS REPORTED BY THE USER FACILITY: "OUR NURSES ARE REPORTING ERRORS WITH THE B BRAUN MACHINES. IT IS GIVING THEM RECURRING ERRORS WITH IVIGS AND THE ERROR MESSAGE IS "UPSTREAM OCCLUSION". THEY TRY MULTIPLE METHODS TO TRY TO CLEAR IT AND IT IS DELAYING PATIENT CARE. ALSO SOME MEDICATIONS CREATE BUBBLES AND AN ERROR "EXCEEDED AIR LIMIT" COMES UP."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15947384 ↗
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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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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