Portex 100/386/010Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019315023385), received between Jul 2, 2019 and Dec 29, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 29, 2021Break; Crack; Break; Crack

  IT WAS REPORTED THAT DURING THE USE OF THE PRODUCT, MEDICAL FLUID LEAKED FROM THE FLAT FILTER. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13115033 ↗
• MalfunctionJul 2, 2019Fluid/Blood Leak; Defective Component; Detachment of Device or Device Component; Incomplete or Inadequate Connection; Fluid/Blood Leak; Defective Component; Detachment of Device or Device Component; Incomplete or Inadequate Connection

  INFORMATION WAS RECEIVED THAT THE SOLDERED COUPLING OF A SMITHS MEDICAL PORTEX EPIDURAL FILTER, FLAT WITH LUER LOCK WAS RELEASED, CAUSING THE CONNECTION ON THE EDA FILTER TO BREAK DURING PATIENT INFUSION. IT WAS ALSO NOTED THERE WAS A SMALL LEAKAGE NEXT TO THE HOSE. SUBSEQUENTLY, THE PATIENT EXPERIENCED BREAKTHROUGH PAIN, BUT NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Inadequate Pain Relief; Pain

  MAUDE report 8755048 ↗