Portex 100/897/090Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019315060458), received between Aug 14, 2019 and Mar 28, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Decrease in Pressure” (1 report).

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.

• InjuryMar 28, 2024Unintended Deflation; Unintended Deflation

  THE REPORT STATED THAT THE TRACHEOSTOMY CUFF WAS NOT HOLDING PRESSURE ON A VENTILATED PATIENT. URGENT TRACHEOSTOMY CHANGE REQUIRED. THE BALLOON FAILURE WAS NOTED ON WED EVENING AND CUFF PRESSURES WERE MONITORED CLOSELY OVERNIGHT AND ADJUSTED REGULARLY- AT TIMES REQUIRING 1/2 HOURLY CHECKS. THE OUTCOME OF THE FAULTY BALLOON IS THAT THE PATIENT REQUIRED VENTILATION FOR LONGER THAN NORMAL AS IT WAS NOT AS EFFECTIVE AS NORMAL. THE TRACHEOSTOMY CHANGE WAS PLANNED FOR THURSDAY OR AN EMERGENCY CHANGE WOULD HAVE BEEN ORGANIZED. IT LASTED FOR 24 DAYS. NORMALLY THE CHANGES ARE PLANNED FOR 28 DAYS. THE SCHEDULE HAD NOT BEEN ADJUSTED AFTER THE EMERGENCY CHANGE AT THE BEGINNING OF FEB AS IN THE NEXT "RISKMAN". THERE WAS PATIENT INVOLVEMENT BUT NO PATIENT HARM/ADVERSE EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Ventilator Dependent

  MAUDE report 18995667 ↗
• MalfunctionMar 11, 2020Disconnection; Disconnection

  INFORMATION WAS RECEIVED INDICATING THAT THE CONNECTOR TO A SMITHS MEDICAL PORTEX® UNIPERC® ADJUSTABLE FLANGE TRACHEOSTOMY TUBE WAS DISCONNECTING FROM THE TUBE 11 DAYS FOLLOWING PLACEMENT. SUBSEQUENTLY, A TRACH TUBE CHANGE OUT WAS PERFORMED. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9821035 ↗
• InjuryAug 14, 2019Leak/Splash; Decrease in Pressure; Material Split, Cut or Torn; Leak/Splash; Decrease in Pressure; Material Split, Cut or Torn

  INFORMATION WAS RECEIVED INDICATING THAT THREE WEEKS FOLLOWING PLACEMENT OF A SMITHS MEDICAL PORTEX® UNIPERC® ADJUSTABLE FLANGE TRACHEOSTOMY TUBE THE CUFF WAS REPORTED TO BE NOT MAINTAINING PRESSURE. AIR WAS ADDED TO THE CUFF BUT THE FOLLOWING DAY, THE CUFF HAD DEFLATED CAUSING THE PATIENT'S OXYGEN SATURATION DECLINE. SUBSEQUENTLY, A TRACH TUBE CHANGE OUT WAS PERFORMED AND THE PATIENT RECOVERED. THERE WERE NO FURTHER REPORTED ADVERSE EFFECTS.

  Patient problems: Hypoxia; Low Oxygen Saturation

  MAUDE report 8895414 ↗