Portex 100/386/010CZRecalls & reported problems
Icu Medical, Inc. · Class 2
All models of Portex (409)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019315107283), received between Sep 11, 2022 and Feb 24, 2026 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fluid/Blood Leak” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Fluid/Blood Leak2
- Air/Gas in Device1
- Disconnection1
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 24, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE FILTER IS FAULTY. IT WAS REPORTED THAT DURING DOSING OF A MALE PATIENT, THE STUDY DRUG LEAKED AT THE CONNECTION POINT BETWEEN THE FILTER AND THE NEEDLE. THE SITE DID NOT REPORT ANY ¿POPPING¿ SOUND WHEN THE FILTER WAS ATTACHED. AN ESTIMATED 1.5 ML OF STUDY DRUG WAS LOST; THE PATIENT WAS SUBSEQUENTLY DOSED WITH THE REMAINING STUDY DRUG IN THE SYRINGE. THE DEVICE WAS HANDLED BY A HEALTHCARE PROFESSIONAL. THERE WAS PATIENT INVOLVEMENT AND NO HUMAN HARM. ASSOCIATED COMPLAINT DOCUMENTED ON (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24434328 ↗MalfunctionJan 29, 2026Fluid/Blood Leak
IT WAS REPORTED THAT THE DEVICE EXHIBITED A LEAKAGE DURING DOSING. THERE WAS UNKNOWN PATIENT INVOLVEMENT, NO INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24211128 ↗MalfunctionApr 1, 2025Disconnection; Disconnection
IT WAS REPORTED THAT THE EPIDURAL CATHETER FILTER BECAME DISCONNECTED FROM WHERE THE BLUE CAP OF THE EPIDURAL CONNECTS TO IT WHILE THE BLUE CAP STILL ATTACHED TO PATIENT. THE EVENT WAS NOTICED ABOUT 2 HOURS AFTER EPIDURAL PLACEMENT. EPIDURAL SEEMED TO OPEN TO AIR FOR UNDETERMINED AMOUNT OF TIME. THERE WAS NO PATIENT HARM OR ADVERSE EVENTS REPORTED AS A RESULT OF THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21746258 ↗MalfunctionSep 11, 2022Air/Gas in Device; Air/Gas in Device
IT WAS REPORTED THAT WHEN PRIMING THE FILTER AN AIR BUBBLE REMAINED AND WAS NOT ABLE TO BE CLEARED. NO PATIENT INJURY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15398005 ↗
Other FILTER, CONDUCTION, ANESTHETIC devices
- Portex 24-1000-64Icu Medical, Inc. · FILTER, CONDUCTION, ANESTHETIC3 reports
- Portex 100/386/010Icu Medical, Inc. · FILTER, CONDUCTION, ANESTHETIC2 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 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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