Bivona FP22JN40NSF099NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517320268), received between Mar 3, 2023 and Mar 6, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Unintended Deflation” (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.

• MalfunctionMar 6, 2023Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT A CUSTOM PEDIATRIC TRACHEOSTOMY TUBE WITH A CAP WAS NOT HOLDING PRESSURE. THE CUFF GRADUALLY DEFLATES AFTER ONE HOUR. THE CUSTOMER PUTS A CAP ON THE CUFF TO STOP IT. PATIENT IS USING TWO (2) TUBES INTERCHANGEABLY, BUT CUFF IS LEAKING. THE CUSTOMER IS UNABLE TO SEND THEM BACK UNTIL REPLACEMENT DEVICES FOR THE PATIENT TO USE ARE RECEIVED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16484655 ↗
• MalfunctionMar 3, 2023Unintended Deflation; Unintended Deflation

  IT WAS REPORTED THAT A CUSTOM PEDIATRIC TRACHEOSTOMY TUBE WITH A CAP WAS NOT HOLDING PRESSURE. THE CUFF GRADUALLY DEFLATES AFTER ONE HOUR. THE CUSTOMER PUTS A CAP ON THE CUFF TO STOP IT. PATIENT IS USING TWO (2) TUBES INTERCHANGEABLY, BUT CUFF IS LEAKING. THE CUSTOMER IS UNABLE TO SEND THEM BACK UNTIL REPLACEMENT DEVICES FOR THE PATIENT TO USE ARE RECEIVED. NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16482458 ↗

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.