Bivona FP18JN40NSF111NRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 15019517169027), received between Dec 31, 2018 and Dec 31, 2018 — classified as 1 injury.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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.

• InjuryDec 31, 2018Detachment of Device or Device Component; Mechanical Jam; Detachment of Device or Device Component; Mechanical Jam

  INFORMATION WAS RECEIVED THAT "THE COLORED END" OF A SMITHS MEDICAL BIVONA CUSTOM FLEXTEND TRACHEOSTOMY TUBE "BROKE OFF AND WAS STUCK INSIDE THE BOLLARD ELBOW" WHILE IN USE WITH A TRACHEOSTOMY (TRACH) AND VENTILATOR DEPENDENT PATIENT. SUBSEQUENTLY, THE PATIENT HAD AN UNSCHEDULED TRACH CHANGE OUT. NO CLINICAL CONSEQUENCES TO THE PATIENT WERE REPORTED AND THE ISSUE NOTED TO BE ONGOING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8206404 ↗

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.