Bivona SU15HN55NSA145NRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 15019517142358), received between Mar 5, 2019 and Jan 3, 2020 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Damaged by Another Device” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2020Material Fragmentation; Material Fragmentation

  INFORMATION WAS RECEIVED INDICATING THAT A PATIENT WITH A SMITHS MEDICAL PORTEX® BIVONA CUSTOMIZED TRACHEOSTOMY TUBE WAS CONNECTED TO A VENTILATOR IN WHICH THE RING WAS OBSERVED TO BREAK OFF. THERE WERE NO REPORTED ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9549555 ↗
• InjuryMar 5, 2019Device Damaged by Another Device; Device Damaged by Another Device

  INFORMATION WAS RECEIVED THAT WHILE IN USE A SMITHS MEDICAL TRACHEOSTOMY SILICONE BIVONA TUBE "BROKE AT THE NECK WHEN THEY ATTACHED AN HME". "TRACED THE HME ON TRACH TUBE AND GETS STUCK. THEY BROKE IT WHILE ATTEMPTING TO REMOVE IT." OF AN UNKNOWN BRAND. SUBSEQUENTLY, A TRACHEOSTOMY TUBE CHANGE OUT WAS PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8392253 ↗
• InjuryMar 5, 2019Device Damaged by Another Device; Device Damaged by Another Device

  INFORMATION WAS RECEIVED THAT WHILE IN USE A SMITHS MEDICAL TRACHEOSTOMY SILICONE BIVONA TUBE "BROKE AT THE NECK WHEN THEY ATTACHED AN HME". "TRACED THE HME ON TRACH TUBE AND GETS STUCK. THEY BROKE IT WHILE ATTEMPTING TO REMOVE IT." OF AN UNKNOWN BRAND. SUBSEQUENTLY, A TRACHEOSTOMY TUBE CHANGE OUT WAS PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8392070 ↗
• InjuryMar 5, 2019Device Damaged by Another Device; Device Damaged by Another Device

  INFORMATION WAS RECEIVED THAT WHILE IN USE A SMITHS MEDICAL TRACHEOSTOMY SILICONE BIVONA TUBE "BROKE AT THE NECK WHEN THEY ATTACHED AN HME". "TRACED THE HME ON TRACH TUBE AND GETS STUCK. THEY BROKE IT WHILE ATTEMPTING TO REMOVE IT." OF AN UNKNOWN BRAND. SUBSEQUENTLY, A TRACHEOSTOMY TUBE CHANGE OUT WAS PERFORMED. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8391662 ↗

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.