Bivona HT16BS45NSB017SRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517040098), received between Aug 7, 2018 and Aug 7, 2018 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (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.

• MalfunctionAug 7, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  INFORMATION WAS RECEIVED INDICATING THAT EXCESSIVE POWDER LIKE MATERIAL WAS NOTED WITHIN A CUFF TO A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE. BLACK AND RED SPECKS OF MATERIAL WERE ALSO NOTED ON THE TRACHEOSTOMY (TRACH) TUBE; WHICH APPEARED TO BE DUSTY AND DIRTY. THE TRACH WAS NOT USED ON THE PATIENT. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7759212 ↗
• MalfunctionAug 7, 2018Contamination /Decontamination Problem; Contamination /Decontamination Problem

  INFORMATION WAS RECEIVED INDICATING THAT EXCESSIVE POWDER LIKE MATERIAL WAS NOTED WITHIN A CUFF TO A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE. BLACK AND RED SPECKS OF MATERIAL WERE ALSO NOTED ON THE TRACHEOSTOMY (TRACH) TUBE; WHICH APPEARED TO BE DUSTY AND DIRTY. THE TRACH WAS NOT USED ON THE PATIENT. THERE WERE NO REPORTED ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7759089 ↗

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.