Portex 101/818/080Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517077544), received between Dec 20, 2021 and Jun 2, 2023 — classified as 1 injury, 1 malfunction.

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. How this data works · Data updated Oct 13, 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.

• MalfunctionJun 2, 2023Break; Sharp Edges; Break; Sharp Edges

  IT WAS REPORTED THAT THE INNER CANNULA WAS LOOSE. THE LENGTH OF THE INNER CANNULA EXCEEDED THE LENGTH OF THE TRACH LEAVING A SHARP EDGE TO COME IN CONTACT WITH THE PATIENTS TRACHEA. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17049217 ↗
• InjuryDec 20, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT THE SUPPLIES WERE TOO BIG AND THAT WHEN CHANGING THEM, THE CLIENT WAS SCRAPED AND HAD TO GO TO THE ER. THE PATIENT WAS GIVEN MEDICATION FOR AN INFECTION.

  Patient problems: Abrasion

  MAUDE report 13048072 ↗