Bivona FU20AN40NSA885NRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 15019517218367), received between Nov 14, 2020 and Nov 14, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Material Discolored” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 14, 2020Material Discolored; Material Discolored

  IT WAS REPORTED THAT SMITHS MEDICAL TRACHS TUBES ARE TURNING YELLOW AT THE BOTTOM AFTER TWO WEEKS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10841041 ↗
• MalfunctionNov 14, 2020Material Discolored; Material Discolored

  IT WAS REPORTED THAT SMITHS MEDICAL TRACHS TUBES ARE TURNING YELLOW AT THE BOTTOM AFTER TWO WEEKS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10841034 ↗
• MalfunctionNov 14, 2020Patient Device Interaction Problem; Patient Device Interaction Problem

  IT WAS REPORTED THAT SMITHS MEDICAL TRACHS TUBES ARE TURNING YELLOW AT THE BOTTOM AFTER TWO WEEKS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10841032 ↗
• MalfunctionNov 14, 2020Material Discolored; Material Discolored

  IT WAS REPORTED THAT SMITHS MEDICAL TRACHS TUBES ARE TURNING YELLOW AT THE BOTTOM AFTER TWO WEEKS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10841029 ↗
• MalfunctionNov 14, 2020Material Discolored; Material Discolored

  IT WAS REPORTED THAT SMITHS MEDICAL TRACHS TUBES ARE TURNING YELLOW AT THE BOTTOM AFTER TWO WEEKS IN USE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10841028 ↗

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.