Bivona FT18DN40NGF999NRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019517146028), received between May 2, 2018 and May 31, 2018 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K923878); they may or may not involve this specific model.

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 31, 2018Inflation Problem; Leak/Splash; Inflation Problem; Leak/Splash

  IT WAS REPORTED THAT A PORTEX® BIVONA CUSTOMIZATION TRACHEOSTOMY TUBE WAS DELIVERED TO THE BEDSIDE AND PLACED IN PATIENT. PER RESPIRATORY THERAPIST (RT) THE PATIENT WAS NOTED TO HAVE A LEAK AND NEEDED MORE STERILE WATER ADDED TO THE CUFF. THE STAFF CHANGED THE TUBE AS THEY WERE CONCERNED ABOUT ADDING MORE STERILE WATER. AFTER REMOVING THE TUBE, IT WAS NOTED THAT WHEN FILLING THE CUFF WITH 3 CC THE CUFF WAS NOT FILLING SYMMETRICALLY. NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7556971 ↗
• InjuryMay 29, 2018Air Leak; Inflation Problem; Air Leak; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT, WHILE IN USE WITH A PATIENT, THIS TRACHEOSTOMY TUBE EXHIBITED LEAKING ISSUES. IT WAS NOTED THAT THE TUBE WAS NOT FILLING SYMMETRICALLY. THE TUBE WAS REMOVED AND REPLACED. NO ADDITIONAL ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7550355 ↗
• MalfunctionMay 2, 2018Air Leak; Inflation Problem; Air Leak; Inflation Problem

  IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE WAS NOT INFLATING PROPERLY, AND THE AIR WAS LEAKING. THE SAME TUBE WAS TRIED TWICE ON THE SAME PATIENT. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7481193 ↗
• MalfunctionMay 2, 2018Air Leak; Inflation Problem; Air Leak; Inflation Problem

  IT WAS REPORTED THAT THE CUFF OF THE TRACHEOSTOMY TUBE WAS NOT INFLATING PROPERLY, AND THE AIR WAS LEAKING. THE SAME TUBE WAS TRIED TWICE ON THE SAME PATIENT. NO INJURY WAS REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7481188 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K923878. One submission often covers many models, so check the product and lot details in each record.

• Z-0260-2007 · Nov 17, 2006 · Terminated
  Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S.