Portex 101/858/090Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517077889), received between Apr 5, 2022 and Apr 5, 2022 — classified as 1 injury.

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 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryApr 5, 2022Break; Break

  IT WAS REPORTED THAT THE RN REMOVED THE INNER CANNULA TO EXCHANGE A NEW ONE AT SHIFT CHANGES. PART OF INNER CANNULA BROKE WHILE RN REMOVED IT SO THE INNER CANULAR WAS STUCK , RN WAS UNABLE TO REMOVE THE BROKEN INNER CANNULA FROM PATIENT TRACHEOSTOMY. TH ISSUE WAS RESOLVED BY REPLACING THE INNER CANNULA SAFELY. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: Device Embedded In Tissue or Plaque; No Clinical Signs, Symptoms or Conditions

  MAUDE report 14014155 ↗