Portex 100/870/075Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019315038792), received between Feb 17, 2016 and Nov 1, 2023 — classified as 2 injuries, 3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryNov 1, 2023Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A "TRACHE TEAM WARD ROUNDING" A CUFF PRESSURE LEAK WAS INVESTIGATED BY "ICU/TRACHE TEAM CONSULTANT AND A/ CNC. CUFF PRESSURE WAS CHECKED AND FOUND TO BE LOWER THAN "20CMH2O". CUFF WAS RE-INFLATED AND RECHECKED AFTER 30MINS AND WAS LOWER THAN "22CMH2O". DECISION WAS MADE TO CHANGE TRACHEOSTOMY TUBE A WEEK BEFORE IT WAS DUE FOR A CHANGE. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18047879 ↗
• MalfunctionApr 22, 2022Component Missing; Component Missing

  IT WAS REPORTED THAT THERE WAS ONLY ONE INNER CANNULA IN THE PACKAGE INSTEAD OF TWO. NO PATIENT INVOLVEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14190099 ↗
• InjuryApr 26, 2021Crack; Gas/Air Leak; Crack; Gas/Air Leak

  IT WAS REPORTED THAT THE TIP OF THE SUBGLOTTIC PORT CRACKED. THERE WAS DIFFICULTY MAINTAINING PRESSURE, AND THERE WERE LESS SECRETIONS BEING ASPIRATED. AN EMERGENT TRACHEOSTOMY TUBE CHANGE WAS PERFORMED AS A RESULT. THE DEFECTIVE DEVICE WAS DISCARDED. THE AFOREMENTIONED PRODUCT PROBLEMS DID NOT CAUSE OR CONTRIBUTE TO AN ADVERSE PATIENT HEALTH EFFECTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11725071 ↗
• MalfunctionJan 20, 2021Inflation Problem; Inflation Problem

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/PVC - PORTEX TUBES BLUE LINE ULTRA (BLU) CUFF DEFLATED AFTER ONE DAY, HE REPORTED PUTTING AIR IN AGAIN AND THE CUFF DEFLATED AGAIN. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11205198 ↗
• MalfunctionFeb 17, 2016Air Leak; Air Leak

  USER FACILITY REPORTED THAT THE DEVICE WAS IN USE WITH PATIENT FOR 20 DAYS. ACCORDING TO REPORTER, AIR WAS FOUND LEAKING FROM THE CUFF AFTER 20 DAYS' USE. NO ADVERSE EFFECTS TO PATIENT REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5442453 ↗