Bivona FT22BN35NGE920NRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019517296372), received between Dec 2, 2022 and Dec 29, 2022 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (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.

• MalfunctionDec 29, 2022Break; Break

  IT WAS REPORTED THAT THE CUSTOMER HAS AN ADDITIONAL CUSTOM TRACH THAT HAD BROKEN. THERE HAS BEEN NO REPORT OF PATIENT INVOLVEMENT OR NO OBSERVABLE CLINICAL SYMPTOMS OR A CHANGE IN SYMPTOMS IDENTIFIED IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16067642 ↗
• InjuryDec 2, 2022Break; Disconnection; Break; Disconnection

  IT WAS REPORTED THAT THE CUSTOMER WAS USING THE TRACHEOSTOMY ON HER (B)(6) DAUGHTER, A PATIENT WITH A CRITICAL AIRWAY THAT CANNOT BE BAGGED OR INTUBATED FROM ABOVE. THE TRACH HAD FALLEN OUT, BUT SHE WAS ABLE TO PUT IT IN RIGHT AWAY. AT THAT TIME IT WAS NOTICED THAT ONE OF THE PHALANGES HAD BROKEN OFF RENDERING THE TRACH USELESS. THE TRACH WAS A BRAND-NEW TRACH AND RECEIVED IN OCTOBER. TWO DIFFERENT TRACHS WERE CHOSEN FOR EMERGENCY REPLACEMENT, HOWEVER THOSE CUFFS WERE FOUND DAMAGED AT THE TIME OF PLACEMENT, ALSO RENDERING THOSE TRACHS USELESS. FOURTH TUBE WAS PLACED SUCCESSFULLY. PATIENT REMAINS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15910548 ↗
• InjuryDec 2, 2022Break; Disconnection; Break; Disconnection

  IT WAS REPORTED THAT THE CUSTOMER WAS USING THE TRACHEOSTOMY ON HER ONE YEAR OLD DAUGHTER, A PATIENT WITH A CRITICAL AIRWAY THAT CANNOT BE BAGGED OR INTUBATED FROM ABOVE. THE TRACH HAD FALLEN OUT, BUT SHE WAS ABLE TO PUT IT IN RIGHT AWAY. AT THAT TIME IT WAS NOTICED THAT ONE OF THE PHALANGES HAD BROKEN OFF RENDERING THE TRACH USELESS. THE TRACH WAS A BRAND-NEW TRACH AND RECEIVED IN OCTOBER. TWO DIFFERENT TRACHS WERE CHOSEN FOR EMERGENCY REPLACEMENT, HOWEVER THOSE CUFFS WERE FOUND DAMAGED AT THE TIME OF PLACEMENT, ALSO RENDERING THOSE TRACHS USELESS. FOURTH TUBE WAS PLACED SUCCESSFULLY. PATIENT REMAINS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15909229 ↗
• InjuryDec 2, 2022Break; Disconnection; Break; Disconnection

  IT WAS REPORTED THAT THE CUSTOMER WAS USING THE TRACHEOSTOMY ON HER ONE YEAR OLD DAUGHTER, A PATIENT WITH A CRITICAL AIRWAY THAT CANNOT BE BAGGED OR INTUBATED FROM ABOVE. THE TRACH HAD FALLEN OUT, BUT SHE WAS ABLE TO PUT IT IN RIGHT AWAY. AT THAT TIME IT WAS NOTICED THAT ONE OF THE PHALANGES HAD BROKEN OFF RENDERING THE TRACH USELESS. THE TRACH WAS A BRAND-NEW TRACH AND RECEIVED IN OCTOBER. TWO DIFFERENT TRACHS WERE CHOSEN FOR EMERGENCY REPLACEMENT, HOWEVER THOSE CUFFS WERE FOUND DAMAGED AT THE TIME OF PLACEMENT, ALSO RENDERING THOSE TRACHS USELESS. FOURTH TUBE WAS PLACED SUCCESSFULLY. PATIENT REMAINS STABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15908862 ↗

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.