Bivona FT16HN60NSC963NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517068085), received between Oct 6, 2019 and Oct 6, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Fungus in Device Environment” (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.

• InjuryOct 6, 2019Fungus in Device Environment; Fungus in Device Environment

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BIVONA CUSTOMER FLEXTEND TTS TRACHEOSTOMY TUBE 19-SEP-2019 MDR=YES. IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE SHOWED SIGNS OF MOLD. NO PATIENT DEATH OR SERIOUS INJURY. THE COMPLAINT DEVICE IS CONSIDERED TO BE A LIFE-SUPPORTING OR LIFE-SUSTAINING DEVICE AND THUS IS ESSENTIAL TO MAINTAINING HUMAN LIFE AS DEFINED IN SECTION 519(F) OF THE FDC ACT. THIS FILE IS CONSIDERED MALFUNCTION REPORTABLE AT THIS TIME. SJ.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9160400 ↗

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.