Bivona FT18DN65NSC129SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517148916), received between Aug 19, 2019 and Oct 13, 2022 — classified as 1 injury, 1 malfunction.

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

• MalfunctionOct 13, 2022Break; Material Too Rigid or Stiff; Break; Material Too Rigid or Stiff

  IT WAS REPORTED THAT THE DEVICE'S SWIVEL CONNECTOR WAS TOO TIGHT, WAS EXTREMELY DIFFICULT TO REMOVE, THE RING BROKE AND THERE WAS A KIND OF BULGE IN THE CANNULA AT THE POINT WHERE THE CUFF STARTS. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15598581 ↗
• InjuryAug 19, 2019Misconnection; Misconnection

  INFORMATION WAS RECEIVED THAT THE SWIVEL CONNECTOR WAS TOO TIGHT ON A SMITHS MEDICAL TRACHEOSTOMY TUBE. INHALATION OR VENTILATION ARE EXTREMELY DIFFICULT TO REMOVE, AND THE RING BROKE AS A RESULT. A BULGE WAS NOTED IN THE CANNULA AT THE POINT WHERE THE TTS CUFF STARTS, SO THAT THE CAREGIVERS WITH THE SUCTION CATHETER DID NOT GET INTO THE CANNULA. NO PATIENT INJURY OCCURED.

  Patient problems: No Information

  MAUDE report 8906412 ↗

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.