Bivona FT19JN40NGE162NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517221312), received between Apr 20, 2023 and Apr 20, 2023 — classified as 2 deaths.

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.

• DeathApr 20, 2023Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  ADDITIONAL INFORMATION RECEIVED VIA EMAIL. IT WAS STATED THAT THE PATIENT PASSED AWAY IN MAY. MEDICAL ASSESSMENT (B)(6) 2024: AS REPORTED THE ORIGINAL COMPLAINTS WERE RELATED TO THE DESCRIPTION OF CUFF DEFLATION OF A CUSTOM BIVONA TUBE. THE MANUFACTURER REACHED OUT SEVERAL TIMES SINCE THE INITIAL REPORT IN (B)(6) 2023 WITH THE LAST CONTACT IN (B)(6) 2023. IT IS REPORTED THAT THE PARENTS DID NOT WANT TO ANSWER ANY ADDITIONAL QUESTIONS RELATED TO THE EVENT BECAUSE THE PATIENT PASSED AWAY IN (B)(6) 2023. THERE IS NO INFORMATION ABOUT THE CAUSE OF THE PATIENT'S DEATH AND NO FURTHER INFORMATION CAN BE OBTAINED FROM THE COMPLAINANT. LACK OF DETAILS REGARDING THIS CLINICAL EVENT PRECLUDES A COMPREHENSIVE MEDICAL ASSESSMENT. BASED ON A REVIEW OF THE EVENTS IN THIS CASE THE CUMULATIVE EVIDENCE OF THIS INCIDENT, IT APPEARS TO EXCLUDE THE BIVONA CUSTOM TUBES AS THE CAUSE OF THE PATIENT EVENT BECAUSE IT WAS REPORTED THAT THE PATIENT TOLERATED THE TRACHEOSTOMY TUBE UNCUFFED AND DEFLATED FROM (B)(6) 2023 UNTIL HER PASSING. PATIENT DEATH IS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS MEDICAL ASSESSMENT WILL BE FURTHER REVISED.

  Patient problems: Insufficient Information

  MAUDE report 16781659 ↗
• DeathApr 20, 2023Leak/Splash; Material Puncture/Hole; Leak/Splash; Material Puncture/Hole

  ADDITIONAL INFORMATION RECEIVED VIA EMAIL. IT WAS STATED THAT THE PATIENT PASSED AWAY IN (B)(6) 2023. MEDICAL ASSESSMENT RECEIVED (B)(6) 2024: AS REPORTED THE ORIGINAL COMPLAINTS WERE RELATED TO THE DESCRIPTION OF CUFF DEFLATION OF A CUSTOM BIVONA TUBE. THE MANUFACTURER REACHED OUT SEVERAL TIMES SINCE THE INITIAL REPORT IN (B)(6) 2023 WITH THE LAST CONTACT IN (B)(6) 2023. IT IS REPORTED THAT THE PARENTS DID NOT WANT TO ANSWER ANY ADDITIONAL QUESTIONS RELATED TO THE EVENT BECAUSE THE PATIENT PASSED AWAY IN (B)(6) 2023. THERE IS NO INFORMATION ABOUT THE CAUSE OF THE PATIENT'S DEATH AND NO FURTHER INFORMATION CAN BE OBTAINED FROM THE COMPLAINANT. LACK OF DETAILS REGARDING THIS CLINICAL EVENT PRECLUDES A COMPREHENSIVE MEDICAL ASSESSMENT. BASED ON A REVIEW OF THE EVENTS IN THIS CASE THE CUMULATIVE EVIDENCE OF THIS INCIDENT, IT APPEARS TO EXCLUDE THE BIVONA CUSTOM TUBES AS THE CAUSE OF THE PATIENT EVENT BECAUSE IT WAS REPORTED THAT THE PATIENT TOLERATED THE TRACHEOSTOMY TUBE UNCUFFED AND DEFLATED FROM (B)(6) 2023 UNTIL HER PASSING. PATIENT DEATH IS REPORTED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THIS MEDICAL ASSESSMENT WILL BE FURTHER REVISED.

  Patient problems: Insufficient Information

  MAUDE report 16781566 ↗

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.