Bivona FT20DN50NSF069NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517226164), received between Sep 28, 2020 and Oct 5, 2020 — classified as 2 malfunctions.

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

• MalfunctionOct 5, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A SMITHS MEDICAL TRACH TUBE LEAKED H2O FROM CUFF CAUSING CUFF TO DEFLATE. TRACH CHANGE WAS NEEDED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10624899 ↗
• MalfunctionSep 28, 2020Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT A SLOW LEAK ON THE CUFF OF A SMITHS MEDICAL TRACH TUBE. THE TUBE HAD A SMALL HOLE IN THE CUFF WHICH WAS LEAKING WATER. TRACH CHANGE WAS NEEDED. NO FURTHER ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10591703 ↗

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.