Portex 100/856/080Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019315052620), received between Apr 10, 2018 and Oct 12, 2022 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Device Markings/Labelling 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 12, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE INNER PACKAGING OF THE DEVICE WAS LABELLED AS A SIZE 8MM INNER CANNULA HOWEVER, UPON OPENING THE PACKAGE, DISCOVERED A SIZE 9MM INNER CANNULA INSIDE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591745 ↗
• MalfunctionOct 12, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT THE INNER PACKAGING OF THE DEVICE WAS LABELLED AS A SIZE 8MM INNER CANNULA. HOWEVER, UPON OPENING THE PACKAGE, DISCOVERED A SIZE 9MM INNER CANNULA INSIDE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591668 ↗
• MalfunctionNov 19, 2018Inaccurate Information; Inaccurate Information

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BLUE LINE TRACHEOSTOMY TUBE INNER CANNULA WAS FOUND TO BE THE WRONG SIZE, THE SIZE 8.0 INNER CANNULA CONTAINED THE 9.0 SIZE INSTEAD. THE PROBLEM WAS DISCOVERED IN USE, WHILE ATTEMPTING TO FIT THE PRODUCT WITH A PATIENT'S TRACHEOSTOMY (TRACH) TUBE. TO RESOLVE THE ISSUE, THE PATIENT'S NURSE WAS ABLE TO USE ANOTHER INNER CANNULA FROM THE SAME LOT THAT WAS THE CORRECT SIZE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8087487 ↗
• MalfunctionNov 19, 2018Inaccurate Information; Inaccurate Information

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL PORTEX BLUE LINE TRACHEOSTOMY TUBE INNER CANNULA WAS FOUND TO BE THE WRONG SIZE, THE SIZE 8.0 INNER CANNULA CONTAINED THE 9.0 SIZE INSTEAD. THE PROBLEM WAS DISCOVERED IN USE, WHILE ATTEMPTING TO FIT THE PRODUCT WITH A PATIENT'S TRACHEOSTOMY (TRACH) TUBE. TO RESOLVE THE ISSUE, THE PATIENT'S NURSE WAS ABLE TO USE ANOTHER INNER CANNULA FROM THE SAME LOT THAT WAS THE CORRECT SIZE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8087481 ↗
• MalfunctionApr 10, 2018Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT THE INNER CANNULA OF A PORTEX® BLUE LINE ULTRA® TRACHEOSTOMY TUBE WAS FOUND TO BE A SIZE 9 INSTEAD OF A SIZE 8. WHEN THE STAFF OPENED THE PACKAGE AND ATTEMPTED TO USE THE TRACHEOSTOMY TUBE, IT WOULD NOT FIT. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7419600 ↗