Bivona 60A150Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15021312005547), received between Oct 25, 2023 and Oct 25, 2023 — classified as 2 injuries.

The most frequently reported specific device problem is “Contamination /Decontamination Problem” (2 reports).

5 other recalls cover devices cleared under the same FDA submission (K083641, K913859); 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 16, 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.

• InjuryOct 25, 2023Dent in Material; Contamination /Decontamination Problem; Dent in Material; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE HAS DEVELOPED ISSUES OVER ONE MONTH. SECRETIONS ARE ADHERING TO ITS OUTER SURFACE, AN INDENTATION ON THE TUBE, AND A NON-SMOOTH SILICONE TEXTURE THAT ENCOURAGES SECRETION BUILDUP. NO INJURY REPORTED. CHEST INFECTION POSSIBLY CAUSED BY THE HARD SET SECRETIONS BEING ON THE OUTER TUBE. AFTER THREE DAYS THE REPLACEMENT TUBE WAS REVIEWED. SECRETIONS AGAIN FOUND STUCK TO THE SIDE OF THE OUTER TUBE. UNDER GUIDANCE FROM "US" THIS WAS AGAIN CHANGED. AGAIN AFTER THREE DAYS FURTHER SECRETIONS WERE FOUND ADHERED TO THE OUTSIDE OF THE TUBE. THE STOMA IS RED, PATIENT HAD CHEST PAIN, REDUCED AIR ENTRY AND STARTED TREATMENT FOR CHEST INFECTION. AUGMENTIN ANTIBIOTICS FOR INFECTION CREATED IN LUNGS. A1: ONE PATIENT, TWO PRODUCT MALFUNCTIONS. (B)(6) BOTH REPRESENT THE SAME PATIENT. THIS IS THE SECOND MALFUNCTION REPORT FOR THE RELATED COMPLAINTS.

  Patient problems: Chest Pain; Low Oxygen Saturation

  MAUDE report 18006329 ↗
• InjuryOct 25, 2023Dent in Material; Contamination /Decontamination Problem; Dent in Material; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THE TRACHEOSTOMY TUBE HAS DEVELOPED ISSUES OVER ONE MONTH. SECRETIONS ARE ADHERING TO ITS OUTER SURFACE, AN INDENTATION ON THE TUBE, AND A NON-SMOOTH SILICONE TEXTURE THAT ENCOURAGES SECRETION BUILDUP. NO INJURY REPORTED. CHEST INFECTION POSSIBLY CAUSED BY THE HARD SET SECRETIONS BEING ON THE OUTER TUBE. THE INITIAL TUBE WAS CHANGED, HARD SECRETIONS CLEANED AND STERILIZED, REPLACED WITH NEW TUBE. THE STOMA IS RED, PATIENT HAD CHEST PAIN, REDUCED AIR ENTRY AND STARTED TREATMENT FOR CHEST INFECTION. AUGMENTIN ANTIBIOTICS FOR INFECTION CREATED IN LUNGS. A1: ONE PATIENT, TWO PRODUCT MALFUNCTIONS. (B)(6) BOTH REPRESENT THE SAME PATIENT. THIS IS THE FIRST MALFUNCTION REPORT FOR THE RELATED COMPLAINTS.

  Patient problems: Chest Pain; Low Oxygen Saturation

  MAUDE report 18005961 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083641, K913859. One submission often covers many models, so check the product and lot details in each record.

• Z-0205-2024 · Aug 22, 2023 · Open, Classified
  Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.
• Z-2946-2020 · Aug 28, 2020 · Terminated
  Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to
• Z-1465-2017 · Feb 9, 2017 · Terminated
  Bivona TTS (Tight to Shaft) Pediatric Tracheostomy Tube, Model No. 67SP035, Reorder No. 67SP035.
• Z-0339-2007 · Aug 31, 2006 · Terminated
  Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm, Length 88 mm, TTS 11.8 mm, Mfrd by Smiths Medical Critical Care; Product code 670185.
• Z-0046-2007 · Aug 11, 2006 · Terminated
  Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D. 8.7 mm, A 7.0 mm, B 0 mm, C 53.0 mm, Mfrd by Smiths Medical Critical Care; REF 60A160.