Bivona FU19AN30NGC082NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517178425), received between May 2, 2019 and May 2, 2019 — classified as 1 malfunction.

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

• MalfunctionMay 2, 2019Defective Device; Defective Device

  IT WAS REPORTED THAT THE TRACH WAS WORN OUT AND CAUSED THE PATIENT TO FEEL SOME IRRITATION AND DISCOMFORT. THIS OCCURRED FOUR DAYS AFTER THE PLACEMENT OF THE TRACH. THE ISSUE WAS CAUSED BY A FLANGE WHICH EXTENDED IN STRAIGHT DIRECTION, LIKE A BAR. THE FLANGE HAD PREVIOUSLY BEEN SHAPED LIKE THE LETTER V. THE TRACH PRESSED AGAINST THE PATIENT'S TRACH SITE. THE CUSTOMER BELIEVED THAT THE BIG CIRCLE DISK IS WHAT WAS PRESSING AGAINST THE TRACH SITE. THE PATIENT'S MOTHER SWITCHED THE PATIENT TO ANOTHER TRACH TUBE AND OBSERVED THE SAME ISSUE. THE MOTHER SUBSEQUENTLY SWITCHED BACK TO THE FIRST TRACH TUBE DISCUSSED ABOVE. THE PATIENT ISSUE REPORTED ABOVE WAS RESOLVED AFTER THE SWITCH WAS MADE TO THE ORIGINAL TRACH TUBE. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED IN CONNECTION WITH THIS EVENT.

  Patient problems: Discomfort; Irritation

  MAUDE report 8574933 ↗

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.