Bivona FF18JN60ZTA113NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517168983), received between Mar 27, 2021 and Mar 27, 2021 — classified as 1 malfunction.

The most frequently reported specific device problem is “Loose or Intermittent Connection” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 27, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  A PATIENT CALLED AND STATED THAT THE PARENT WAS UNABLE TO DISCONNECT A VENTILATOR CIRCUIT FROM THE TRACHEOSTOMY TUBE. TWO CCNS ATTENDED THE HOME AND IN THE END AS THEY WERE ALSO UNABLE TO DISCONNECT IT, THEY CARRIED OUT AN EMERGENCY TUBE CHANGE. THE END OF THE TRACH WAS WEDGED INTO THE SWIVEL ELBOW. THE TOP TRACHEOSTOMY IN THE PICTURE IS JUST TO SHOW THE PART THAT CAME AWAY. THE TUBE WAS CHANGED 2 WEEKS AGO. IT WAS STILL IN THE RECOMMENDED TIMEFRAME FOR CHANGING THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11579463 ↗

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.