Bivona FT18BN45NSF878NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517142747), received between Apr 10, 2018 and Apr 10, 2018 — classified as 1 malfunction.

The most frequently reported specific device problem is “Deflation Problem” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2018Deflation Problem; Deflation Problem

  IT WAS REPORTED THAT THE CUFF OF A PORTEX® BIVONA® CUSTOM TTS¿ TRACHEOSTOMY TUBE WAS DIFFICULT TO DEFLATE DURING THE TIME OF THE PATIENT'S FIRST AIRWAY CHANGE. DURING REMOVAL, THE BESIDE RESPIRATORY THERAPIST FELT A SLIGHT RESISTANCE. THE RESPIRATORY THERAPIST INITIALLY THOUGHT THE RESISTANCE WAS DUE TO THE PATIENT'S "AIRWAY ISSUES". UPON LOOKING AT THE CUFF, IT WAS DETERMINED THE CUFF WAS STILL INFLATE WITH AT LEAST 2ML OF WATER. IT WAS STATED THAT THE SITUATION WAS "CONTROLLED" AND THERE WAS NO INJURY TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7419524 ↗

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.