Portex 100/870/070Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019315038785), received between Jun 18, 2020 and Jun 29, 2021 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Gas/Air Leak” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 29, 2021Gas/Air Leak; Gas/Air Leak

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES BLUE LINE ULTRA (BLU) WAS LEAKING AFTER 5-8 HOURS . REPORTED FOUR UNITS IN TWO PATIENT AND WAS TESTED PRIOR NORMAL WITH FOUR UNITS. NO PATIENT ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12086542 ↗
• MalfunctionJun 29, 2021Gas/Air Leak; Gas/Air Leak

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES BLUE LINE ULTRA (BLU) WAS LEAKING AFTER 5-8 HOURS . REPORTED FOUR UNITS IN TWO PATIENT AND WAS TESTED PRIOR NORMAL WITH FOUR UNITS. NO PATIENT ADVERSE EVENTS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12086469 ↗
• InjuryJun 18, 2020Naturally Worn; Naturally Worn

  INFORMATION WAS RECEIVED INDICATING THAT THE FLANGE TO A SMITHS MEDICAL PORTEX BLUE LINE ULTRA TRACHEOSTOMY TUBE WAS OBSERVED TO BE DAMAGED FOLLOWING 8 DAYS OF USE. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10171404 ↗