Bivona FA18KN65NSZ038NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517170962), received between Feb 26, 2021 and Feb 26, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Fluid/Blood Leak” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2021Fluid/Blood Leak; Fluid/Blood Leak

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES CUSTOM MALFUNCTIONED .REPORTED NEW TRACH INSERTED DURING ROUTINE CHANGE. WAS TAKEN OUT THE NEXT DAY BECAUSE THE PILOT BALLOON PORT WAS PUSHED IN WEIRD. THE NURSE TOOK OUT THE NEW ONE AND PUT THE OLD ONE BACK IN. NO PATIENT HARM, PATIENT CONDITION STABLE. THE EVENT DESCRIBED ROUTINE CHANGE AS THIS WOULD INDICATE A TRACH IN LONG TERM USE, WHICH WOULD NOT REQUIRE EMERGENT TRACH CHANGE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11388706 ↗

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.