Bivona FT22BN35NSE019NRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 15019517294255), received between Sep 1, 2022 and Sep 1, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT THE TRACH TUBE FLANGE WAS FOUND ALMOST BROKEN THROUGH. TRACH WAS CHANGED WITHOUT ISSUE. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER SPECIFIC DETAILS ON THIS INCIDENT WERE RECEIVED. ITEM LOT NUMBER IS UNKNOWN. NO PATIENT INJURY OR ADVERSE EFFECTS AFTER THE TRACH CHANGE WAS COMPLETED, WERE REPORTED.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 15340463 ↗
• InjurySep 1, 2022Break; Material Separation; Break; Material Separation

  IT WAS REPORTED THAT AN RN ATTEMPTED TO DISCONNECT A VENTILATOR FROM THE TRACHEOSTOMY TUBE AND NOTICED THAT THE PLASTIC ON THE TRACHEOSTOMY TUBE WAS BROKEN. TRACHEOSTOMY TUBE CHANGED WITH NO ISSUES AND NO HARM TO PATIENT. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER SPECIFIC DETAILS ON THIS INCIDENT WERE RECEIVED. ITEM LOT NUMBER IS UNKNOWN.

  Patient problems: Decreased Respiratory Rate

  MAUDE report 15340241 ↗
• MalfunctionSep 1, 2022Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED THAT A HOLE WAS FOUND IN THE INFLATION LINE WHERE THE LINE CONNECTS TO FLANGE. ADDITIONAL INFORMATION WAS REQUESTED; HOWEVER, NO FURTHER SPECIFIC DETAILS ON THIS INCIDENT WERE RECEIVED. ITEM LOT NUMBER IS UNKNOWN. NO PATIENT INJURY OR ADVERSE AFFECTS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15336508 ↗

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.