Portex 100/134/050Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019315020872), received between Feb 10, 2021 and Feb 10, 2021 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Labelling, Instructions for Use or Training Problem” (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 16, 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.

• MalfunctionFeb 10, 2021Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT PORTEX ENDOTRACHEAL TUBES DID NOT HAVE MARKINGS ON THE VOCAL CORDS WITH SIZES 5, 5.5, AND 5.6. THE PRODUCT PROBLEM WAS OBSERVED UPON OPENING OF THE PACKAGE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Information

  MAUDE report 11308791 ↗
• MalfunctionFeb 10, 2021Labelling, Instructions for Use or Training Problem; Labelling, Instructions for Use or Training Problem

  IT WAS REPORTED THAT PORTEX ENDOTRACHEAL TUBES DID NOT HAVE MARKINGS ON THE VOCAL CORDS WITH SIZES 5, 5.5, AND 5.6. THE PRODUCT PROBLEM WAS OBSERVED UPON OPENING OF THE PACKAGE. NO PATIENT INJURY OR COMPLICATIONS WERE REPORTED IN RELATION TO THIS EVENT.

  Patient problems: No Information

  MAUDE report 11308342 ↗