Portex 101/856/080Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 15019517077797), received between May 7, 2024 and Sep 4, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Fitting Problem” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2024Mechanical Problem; Nonstandard Device; Fitting Problem; Mechanical Problem; Nonstandard Device; Fitting Problem

  IT WAS REPORTED THAT THE INNER CANNULAS FAILED TO SECURE TO THE TRACH. THE CUSTOMER MENTIONED THAT THIS WAS THE SECOND TIME THEY HAD NOTICED THE ISSUE. THE FIRST WAS APPROXIMATELY A MONTH AGO. THREE BOXES OF 20 WERE INVOLVED IN THE EVENT. THERE WAS UNKNOWN PATIENT INVOLVEMENT AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20135197 ↗
• MalfunctionAug 22, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING A ROUTINE CANNULA CHANGE THE CANNULA WOULD NOT "CLICK" IN. THERE WAS PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20027508 ↗
• MalfunctionAug 21, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT THE INNER CANNULA WOULD NOT LOCK INTO THE TRACH. THERE WAS PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20010317 ↗
• MalfunctionAug 20, 2024Fitting Problem; Fitting Problem

  IT WAS REPORTED THAT DURING A ROUTINE CANNULA CHANGE, THE INNER CANNULA WOULD NOT LOCK INTO THE TRACH. THERE WAS PATIENT INVOLVEMENT, AND NO ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20007582 ↗
• MalfunctionAug 13, 2024Misconnection; Misconnection

  IT WAS REPORTED THAT THE CANNULA WAS NOT CLICKING INTO THE TRACH AS IT SHOULD. THE EVENT OCCURRED BEFORE PATIENT USE, AND NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973578 ↗
• MalfunctionAug 13, 2024Misconnection; Misconnection

  IT WAS REPORTED THAT THE CANNULA WAS NOT CLICKING INTO THE TRACH AS IT SHOULD. THE EVENT OCCURRED BEFORE PATIENT USE, AND NO PATIENT HARM/ADVERSE EVENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19973576 ↗
• MalfunctionJun 25, 2024Misconnection; Misconnection

  IT WAS REPORTED THAT THE INNER CANNULA WAS NOT CLICKING OR LOCKING INTO PLACE. THERE WAS A PATIENT INVOLVEMENT AND NO PATIENT HARM REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19610089 ↗
• MalfunctionMay 7, 2024Separation Problem; Separation Problem

  IT WAS REPORTED THAT THE INNER CANNULAS DOES NOT CLICK IN AND POPS OUT. PATIENT INVOLVEMENT AND ADVERSE PATIENT EFFECTS ARE UNKNOWN/UNCLEAR.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 19260641 ↗