Bivona FT19KN55NGF941NRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019517211825), received between Dec 20, 2019 and Dec 20, 2019 — classified as 4 injuries.

The most frequently reported specific device problem is “Leak/Splash” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryDec 20, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE "BLEW." THE PATIENT WAS REPORTED TO HAVE AN AUDIBLE LEAK WITH NO ETCO2 AND DECREASED TIDAL VOLUMES. ENT WAS CALLED TO ASSIST SINCE THE PATIENT HAD A HISTORY OF BEING A DIFFICULT AIRWAY. SUBSEQUENTLY, THE TRACH TUBE WAS CHANGED OUT. THE FOLLOWING NIGHT, A LEAK WAS REPORTED TO HAVE DEVELOPED WITH THE REPLACEMENT TRACH. THE PATIENT IS STABLE BUT IS VENTILATOR DEPENDENT AND IS AWAITING REPLACEMENT TRACH TUBE. THE TUBES WERE LATER RETURNED FOR ANALYSIS.

  Patient problems: No Code Available

  MAUDE report 9506357 ↗
• InjuryDec 20, 2019Leak/Splash; Material Puncture/Hole; Scratched Material; Leak/Splash; Material Puncture/Hole; Scratched Material

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE "BLEW." THE PATIENT WAS REPORTED TO HAVE AN AUDIBLE LEAK WITH NO ETCO2 AND DECREASED TIDAL VOLUMES. ENT WAS CALLED TO ASSIST SINCE THE PATIENT HAD A HISTORY OF BEING A DIFFICULT AIRWAY. SUBSEQUENTLY, THE TRACH TUBE WAS CHANGED OUT. THE FOLLOWING NIGHT, A LEAK WAS REPORTED TO HAVE DEVELOPED WITH THE REPLACEMENT TRACH. THE PATIENT IS STABLE BUT IS VENTILATOR DEPENDENT AND IS AWAITING REPLACEMENT TRACH TUBE. THE TUBES WERE LATER RETURNED FOR ANALYSIS.

  Patient problems: No Code Available

  MAUDE report 9506356 ↗
• InjuryDec 20, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE "BLEW." THE PATIENT WAS REPORTED TO HAVE DECREASED TIDAL VOLUMES, VITALS DECOMPENSATED HIGH CO2, AND AN AUDIBLE LEAK WAS NOTED THE TRACH TUBE WAS IMMEDIATELY CHANGED OUT. ENT WAS CALLED TO THE BEDSIDE OF THE PATIENT TO ASSIST WITH THE PLACEMENT. SUBSEQUENTLY, AT APPROXIMATELY 3AM, THE REPLACEMENT TUBE ALSO LEAKED. THE PATIENT IS REPORTED TO BE STABLE BUT IS AWAITING A NEW BACK-UP TRACH TUBE. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: Respiratory Acidosis

  MAUDE report 9506248 ↗
• InjuryDec 20, 2019Leak/Splash; Leak/Splash

  INFORMATION WAS RECEIVED INDICATING THAT THE CUFF TO A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE "BLEW." THE PATIENT WAS REPORTED TO HAVE DECREASED TIDAL VOLUMES, VITALS DECOMPENSATED HIGH CO2, AND AN AUDIBLE LEAK WAS NOTED THE TRACH TUBE WAS IMMEDIATELY CHANGED OUT. ENT WAS CALLED TO THE BEDSIDE OF THE PATIENT TO ASSIST WITH THE PLACEMENT. SUBSEQUENTLY, AT APPROXIMATELY 3AM, THE REPLACEMENT TUBE ALSO LEAKED. THE PATIENT IS REPORTED TO BE STABLE BUT IS AWAITING A NEW BACK-UP TRACH TUBE. THE PRODUCT WAS RETURNED FOR ANALYSIS.

  Patient problems: Respiratory Acidosis

  MAUDE report 9506170 ↗

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.