Bivona FT19BN50NGA037NRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 15019517180930), received between Aug 19, 2019 and Aug 19, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Material Puncture/Hole” (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.

• InjuryAug 19, 2019Material Puncture/Hole; Material Puncture/Hole

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BIVONA CUSTOM FLEXTEND TRACHEOSTOMY TUBE WAS IN USE WITH A PATIENT ON A VENTILATOR OF AN UNKNOWN BRAND AT THEIR HOME. IT WAS REPORTED THE PATIENT'S VENTILATOR WOULD NOT STOP ALARMING, SO THE PATIENT'S MOTHER TRIED SUCTIONING THE TUBE TO SEE IF IT WOULD RESOLVE THE ALARM. WHEN THE ALARMING CONTINUED, THE TRACHEOSTOMY (TRACH) TUBE WAS REMOVED AND FOUND TO HAVE A HOLE IN IT. A NEW TRACH WAS INSERTED, BUT THE VENTILATOR KEPT ALARMING. SUBSEQUENTLY, THE PATIENT'S SECOND TRACH WAS TAKEN OUT AND WAS FOUND TO HAVE A HOLE IN IT AS WELL. WHEN A THIRD TRACH WAS PLACED INTO THE PATIENT, THE VENTILATOR ALARMING RESOLVED. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8906634 ↗
• InjuryAug 19, 2019Material Puncture/Hole; Material Puncture/Hole

  INFORMATION WAS RECEIVED THAT A SMITHS MEDICAL BIVONA CUSTOM FLEXTEND TRACHEOSTOMY TUBE WAS IN USE WITH A PATIENT ON A VENTILATOR OF AN UNKNOWN BRAND AT THEIR HOME. IT WAS REPORTED THE PATIENT'S VENTILATOR WOULD NOT STOP ALARMING, SO THE PATIENT'S MOTHER TRIED SUCTIONING THE TUBE TO SEE IF IT WOULD RESOLVE THE ALARM. WHEN THE ALARMING CONTINUED, THE TRACHEOSTOMY (TRACH) TUBE WAS REMOVED AND FOUND TO HAVE A HOLE IN IT. A NEW TRACH WAS INSERTED, BUT THE VENTILATOR KEPT ALARMING. SUBSEQUENTLY, THE PATIENT'S SECOND TRACH WAS TAKEN OUT AND WAS FOUND TO HAVE A HOLE IN IT AS WELL. WHEN A THIRD TRACH WAS PLACED INTO THE PATIENT, THE VENTILATOR ALARMING RESOLVED. THERE WERE NO ADVERSE PATIENT EFFECTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8906632 ↗

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.