Bivona FT14DN50NSA090NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10351688735959), received between Nov 21, 2023 and Nov 21, 2023 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Defective Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 21, 2023Defective Component; Defective Device; Device Misassembled During Manufacturing /Shipping; Defective Component; Defective Device; Device Misassembled During Manufacturing /Shipping

  IT WAS REPORTED THAT THE CUFF, NEAR THE TIP, WAS ATTACHED LOWER ON THE LEFT SIDE THAN THE RIGHT. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER, AND THE OUTCOME OF THE EVENT WAS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187533 ↗
• MalfunctionNov 21, 2023Inflation Problem; Material Deformation; Inflation Problem; Material Deformation

  IT WAS REPORTED THAT THE TRACH HAD A DISTORTED CUFF. THE CUSTOMER TRIED INFLATING THE CUFF MORE TO SEE IF IT WAS STUCK. THEY ALSO TRIED APPLYING PRESSURE TO THE LARGER SIDE TO SEE IF IT WOULD RECENTER, BUT DID NOT WORK. NO ADVERSE PATIENT EFFECTS WERE REPORTED BY THE CUSTOMER, AND THE OUTCOME OF THE EVENT WAS ONGOING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18187468 ↗

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.