Bivona FT18DN35NGF006NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517146264), received between Sep 19, 2018 and Sep 28, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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.

• MalfunctionSep 28, 2018Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE LEAKED 0.2MLS FOLLOWING BY ANOTHER 0.2MLS OVER THE NEXT 12 HOURS. SUBSEQUENTLY, THE BACKUP TRACHEOSTOMY (TRACH) WAS REQUIRED TO BE PLACED. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7918521 ↗
• MalfunctionSep 19, 2018Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT THE CUSTOM SILICONE BIVONA TRACHEOSTOMY TUBE WAS PLACED AT 7 A.M., BY 3 P.M., THE TRACHEOSTOMY TUBE HAD LEAKED BY A VALUE OF 20%. NO DEATH OR SERIOUS INJURY WAS REPORTED IN CONNECTION WITH THIS INCIDENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7891746 ↗

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.