Bivona FT19FN35NGE076SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517195507), received between Dec 30, 2019 and Mar 17, 2020 — 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.

• MalfunctionMar 17, 2020Material Rupture; Material Split, Cut or Torn; Material Rupture; Material Split, Cut or Torn

  INFORMATION WAS RECEIVED THAT SMITHS BIVONA® ADULT TTS¿ TRACHEOSTOMY TUBE REPORTED DURING CLEANING, A SMALL PIECE OF PLASTIC WAS NOTICED COMING OUT OF THE PILOT LINE. THE USER WAS CONCERNED OVER FOREIGN BODY BEING INGESTED INTO THE STOMA. NO PATIENT ADVERSE EVENTS REPORTED AND A NEW TRACH CHANGE TOOK PLACE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9845167 ↗
• InjuryDec 30, 2019Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BIVONA CUSTOM 3.5 FLEXTEND NS TRACHEOSTOMY TUBE WAS IN USE AND REUSED WITH A PATIENT FOR SIXTEEN DAYS. THE DEVICE WAS CLEANED AND PROCESSED BY MANUFACTURER'S GUIDELINES PER THE REPORTER. HOWEVER, IT WAS REPORTED THAT ONE DAY AFTER RE-PLACING THE TRACHEOSTOMY (TRACH) TUBE, THE PATIENT'S MOTHER HEARD AN AIR LEAK. THE REPORTER STATED THE TRACH CAME APART AT THE CONNECTION OF THE SHAFT AND THE HUB. SUBSEQUENTLY, A TUBE CHANGE OUT BY THE PATIENT'S CAREGIVER WAS REQUIRED. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9532670 ↗

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.