Medex MBF27Recalls & 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
- 11
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10351688510471), received between Feb 8, 2019 and May 30, 2025 — classified as 7 injuries, 4 malfunctions.
The most frequently reported specific device problem is “Break” (10 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
- Break10
- Fluid/Blood Leak2
- Fracture1
- Material Separation1
Patient problems
- Unspecified Infection7
- No Clinical Signs, Symptoms or Conditions4
- Insufficient Information1
Recent adverse event reports
The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.
MalfunctionMay 30, 2025Break; Break
IT WAS REPORTED THAT WHEN TEMPORARILY DISCONNECTING A BIFURCATE FROM THE PATIENT'S PORT, THE COLLAR OF THE BIFURCATE COMPLETELY BROKE AND SLID OFF THE BIFURCATE. THERE WAS PATIENT INVOLVEMENT, AND "MINIMUM" PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22116692 ↗MalfunctionFeb 7, 2025Break; Break
IT WAS REPORTED THAT WHEN TEMPORARILY DISCONNECTING A BIFURCATE FROM THE PATIENT'S PORT, THE COLLAR OF THE BIFURCATE COMPLETELY BROKE AND SLID OFF THE BIFURCATE. THERE WAS PATIENT INVOLVEMENT, AND "MINIMUM" PATIENT HARM/ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21335434 ↗MalfunctionJun 28, 2023Fluid/Blood Leak; Fracture; Fluid/Blood Leak; Fracture
ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE ITEM WAS BROKEN DURING PATIENT USE, BUT PATIENT WAS NOT HARMED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17218208 ↗MalfunctionJun 22, 2023Break; Fluid/Blood Leak; Material Separation; Break; Fluid/Blood Leak; Material Separation
ADDITIONAL INFORMATION WAS RECEIVED CONFIRMING THE ITEM WAS BROKEN DURING PATIENT USE, BUT PATIENT WAS NOT HARMED. THERE WAS A DELAY IN THERAPY IN ORDER TO SWAP OUT COMPONENTS DUE TO BROKEN LINE. NO PATIENT ADVERSE EFFECTS REPORTED. THE REPORTER STATED THAT THESE WERE THE POTENTIAL LOT NUMBERS: 4319536, 4215451, AND 4340434.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17187064 ↗InjuryFeb 8, 2019Break; Break
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL MEDEX ADMINISTRATION SET HAD A CRACK IN THE HUB CONNECTION. PATIENT WAS NOTED TO HAVE ACQUIRED A BLOOD INFECTION. A NEW STERILE LINE CHANGE WAS DONE IMMEDIATELY.
Patient problems: Unspecified Infection
MAUDE report 8323515 ↗InjuryFeb 8, 2019Break; Break
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL MEDEX ADMINISTRATION SET HAD A CRACK IN THE HUB CONNECTION. PATIENT WAS NOTED TO HAVE ACQUIRED A BLOOD INFECTION. A NEW STERILE LINE CHANGE WAS DONE IMMEDIATELY.
Patient problems: Unspecified Infection
MAUDE report 8323510 ↗InjuryFeb 8, 2019Break; Break
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL MEDEX ADMINISTRATION SET HAD A CRACK IN THE HUB CONNECTION. PATIENT WAS NOTED TO HAVE ACQUIRED A BLOOD INFECTION. A NEW STERILE LINE CHANGE WAS DONE IMMEDIATELY.
Patient problems: Unspecified Infection
MAUDE report 8323509 ↗InjuryFeb 8, 2019Break; Break
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL MEDEX ADMINISTRATION SET HAD A CRACK IN THE HUB CONNECTION. PATIENT WAS NOTED TO HAVE ACQUIRED AN INFECTION. AS A RESULT, A COMPLETE STERILE LINE CHANGE WAS DONE IMMEDIATELY. PATIENT WAS GIVEN ANTIBIOTICS AND TRANSFERRED TO SURGICAL CENTER. IT WAS REPORTED THAT PATIENT HAS RECOVERED.
Patient problems: Unspecified Infection
MAUDE report 8323508 ↗InjuryFeb 8, 2019Break; Break
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL MEDEX ADMINISTRATION SET HAD A CRACK IN THE HUB CONNECTION. PATIENT WAS NOTED TO HAVE ACQUIRED AN INFECTION. A NEW STERILE LINE CHANGE WAS DONE IMMEDIATELY. ANTIBIOTICS WERE ADMINISTERED AND PATIENT WAS TRANSFERRED TO SURGICAL CENTER.
Patient problems: Unspecified Infection
MAUDE report 8323507 ↗InjuryFeb 8, 2019Break; Break
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL MEDEX ADMINISTRATION SET HAD A CRACK IN THE HUB CONNECTION. PATIENT WAS NOTED TO HAVE ACQUIRED AN INFECTION. AS A RESULT, A COMPLETE STERILE LINE CHANGE WAS DONE IMMEDIATELY.
Patient problems: Unspecified Infection
MAUDE report 8323505 ↗InjuryFeb 8, 2019Break; Break
INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL MEDEX ADMINISTRATION SET HAD A CRACK IN THE HUB CONNECTION. PATIENT WAS NOTED TO HAVE ACQUIRED A BLOOD INFECTION. A NEW STERILE LINE CHANGE WAS DONE IMMEDIATELY.
Patient problems: Unspecified Infection
MAUDE report 8323504 ↗
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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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