Medex BF100Recalls & reported problems
Icu Medical, Inc. · Class 2
All models of Medex (98)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10351688511980), received between May 20, 2021 and Mar 20, 2024 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).
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
- Fluid/Blood Leak1
- Improper Chemical Reaction1
- Insufficient Flow or Under Infusion1
- Material Puncture/Hole1
- Optical Discoloration1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 20, 2024Improper Chemical Reaction; Optical Discoloration; Improper Chemical Reaction; Optical Discoloration
IT WAS REPORTED THAT A PATIENT RECEIVED CHEMOTHERAPY AGENT THRU THIS TUBING AND ONE LUMEN BECAME CLOUDY/DISCOLORED NOT DUE TO PRECIPITATE BUT RATHER LIKE A CHEMICAL REACTION OCCURRED WITH THE PLASTIC. THERE HAS A PATIENT INVOLVEMENT AND UNKNOWN PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: Insufficient Information
MAUDE report 18945344 ↗InjuryMay 20, 2021Fluid/Blood Leak; Material Puncture/Hole; Insufficient Flow or Under Infusion; Fluid/Blood Leak; Material Puncture/Hole; Insufficient Flow or Under Infusion
INFORMATION RECEIVED A SMITHS MEDICAL INFUSION EXTENSION SETS AND DISPOSABLES/MEDEX EXTENSION SETS MULTI LINE HAD OPEN LINE. THE RN FOUND LEAKING AT THE Y-CONNECTOR ON MAIN INFUSION LINE. PROVIDERS CONSIDERED IT A LINE BREAK. CULTURES DRAWN AND ANTIBIOTICS GIVEN TO AN ONCOLOGY PATIENT, DUE TO THE INVASIVE LINE BEING CENTRAL LINE. THIS PATIENT WAS CONSIDERED IMMUNE COMPROMISED. CULTURES CAM E BACK NEGATIVE.. NO SERIOUS INJURY OCCURRED BUT MAY HAVE OCCURRED WITH MALFUNCTION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11860182 ↗
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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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