Portex 101/815/090Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019517077384), received between Jun 23, 2021 and May 26, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Defective Component” (3 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.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 26, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT UPON OPENING SAMPLE TRACH TO EXAMINE NEW PRODUCT, THAT BOTH INNER CANNULAS THAT CAME IN THE PACKAGING EXTENDED PAST END OF TRACH. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17009424 ↗
• MalfunctionMay 11, 2023Defective Component; Defective Component

  IT WAS REPORTED UPON OPENING THE SAMPLE TRACH TO EXAMINE NEW PRODUCT AND DISCOVERED THE INNER CANNULA THAT CAME WITH PRODUCT EXTENDED PAST END OF TRACH. BOTH INNER CANNULA IN PACKAGE DID THIS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911665 ↗
• MalfunctionMay 11, 2023Defective Component; Defective Component

  IT WAS REPORTED, THAT THE INNER CANNULA EXTENDS PAST THE END OF THE TRACH. AT LEAST 2MILLIMETERS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16911592 ↗
• MalfunctionJun 23, 2021Difficult to Remove; Difficult to Remove

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES BLUSELECT WAS FOUND TO BE DEVIATED DOWNWARD, MAKING IT DIFFICULT TO REMOVE THE INNER CANNULA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12051589 ↗