Bivona 67PFS30Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 10351688518606), received between Mar 10, 2020 and Jul 20, 2023 — classified as 1 injury, 8 malfunctions.

The most frequently reported specific device problem is “Inflation Problem” (5 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. May 29, 2024Class IOpen, Classified

   Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.

   Z-2613-2024 · Root cause: Under Investigation by firm · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 20, 2023Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT AN OXYGEN-DEPENDENT PATIENT WITH COMPLETE ATRIOVENTRICULAR CANAL WITH UNFAVORABLE EVOLUTION AFTER SURGERY ON (B)(6) 2023 HAS BEEN VENTILATED ON A TRACHEOSTOMY CANNULA SINCE (B)(6) 2023. WHEN CHANGING THE CANNULA, THE PROFESSIONALS HAVE DIFFICULTY WITH THE BALLOON, WHICH DOES NOT INFLATE IN A CONSISTENT MANNER. THERE WAS DELAYED RESUMPTION OF VENTILATION, WITH DEEP DESATURATION (17%) AND BRADYCARDIA AT 80BPM. CHANGE OF CANNULA FROM THE SAME BATCH, WHICH INFLATES BETTER. PROFESSIONALS DID NOT MASSAGE THE BALLOON BEFORE ATTEMPTING INFLATION WITH PPI WATER. THE OUTCOME OF THE EVENT WAS RESOLVED. A SECOND CANNULA WAS DOCUMENTED ON (B)(4).

  Patient problems: Bradycardia; Low Oxygen Saturation

  MAUDE report 17368460 ↗
• MalfunctionOct 18, 2022Defective Device; Defective Device

  IT WAS REPORTED THAT THE CUFF OF THE CANULA IS DEFECTIVE AFTER 2 STERILIZATION (VS 5 STERILIZATION RECOMMENDED BY THE MANUFACTURER). CUSTOMER REQUIRES A REPLACEMENT OR CREDIT. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15624908 ↗
• MalfunctionOct 29, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT A SMITHS MEDICAL TRACH TUBE HAD AN UNKNOWN ISSUE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12724699 ↗
• MalfunctionOct 29, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT THE CUFF NOT INFLATING. A SMITHS MEDICAL TRACH TUBE. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12724363 ↗
• MalfunctionOct 28, 2021Inflation Problem; Inflation Problem

  IT WAS REPORTED THAT TWO TRACHS WERE LISTED AS CUFFS NOT INFLATING. ONE TRACH WITH AN UNKNOWN ISSUE.

  Patient problems: Insufficient Information

  MAUDE report 12716063 ↗
• MalfunctionSep 17, 2021Failure to Clean Adequately; Failure to Clean Adequately

  INFORMATION WAS RECEIVED INDICATING THAT UPON REMOVAL OF A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED FLEXTEND AND CLEANING THE TUBE, THE TUBE BECAME OPAQUE, DIRTY, STAINED AND DIFFICULT TO DRY. THE TUBE WAS UNABLE TO BE USED. NO ADVERSE EFFECTS WERE REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 12488788 ↗
• InjuryJun 2, 2020Fluid/Blood Leak; Detachment of Device or Device Component; Fluid/Blood Leak; Detachment of Device or Device Component

  INFORMATION RECEIVED A SMITHS MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED FLEXTEND CUFF DEFLATED AS PATIENT WAS ABLE TO PULL THE DEVICE OUT AND EXTUBATE THE AIRWAY. THIS IN TURN CAUSED THE OXYGEN SATURATION TO FALL BELOW NORMAL AND AN EMERGENT TRACHEOSTOMY CHANGE WAS PERFORMED. WHEN THE DEVICE WAS TESTED AFTER INCIDENT, IT WAS DISCOVERED THE WATER STAYED IN THE PILOT BALLOON AND NOT BALLOON ITSELF. NO OTHER CLINICAL INJURES WERE REPORTED, AS THE ISSUE WAS RESOLVED WITH TRACHEOSTOMY CHANGE OUT.

  Patient problems: Hypoxia

  MAUDE report 10110986 ↗
• MalfunctionApr 30, 2020Leak/Splash; Leak/Splash

  INVESTIGATION COMPLETED ON A SMITHS MEDICAL INVESTIGATION COMPLETED ON A SMITH MEDICAL TRACHEOSTOMY/SILICONE - BIVONA TUBES NEO/PED. SUMMARY IN H-10.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10012629 ↗
• MalfunctionMar 10, 2020Inflation Problem; Inflation Problem

  INFORMATION WAS RECEIVED INDICATING THAT A SMITHS MEDICAL PORTEX BIVONA FLEXTEND¿ TTS¿ TRACHEOSTOMY TUBE WAS NOTED TO BE STAINED ORANGE ON THE INSIDE AND THAT THE CUFF NEEDED RE-INFLATING. IT WAS REPORTED THAT WHEN THE PATIENT CRIED, UNUSUAL SOUNDS CAME FROM THE TRACH AREA AND THAT 2MLS OF WATER WAS REQUIRED TO RE-INFLATE THE CUFF; AS THE WATER THAT WAS INITIALLY IN THE CUFF HAD GONE INTO THE PATIENT'S LUNGS. THE PHYSICIAN WAS NOTIFIED, AND THE PATIENT SHOWED SIGNS OF RESPIRATORY DISTRESS, PALLOR, SWEATING, CYANOSIS, UNCONSCIOUS AND O2 SATURATION BELOW 50%. SUBSEQUENTLY, AN EMERGENT TRACH TUBE CHANGE OUT WAS PERFORMED AND THE VENTILATOR WAS RECONNECTED, THE PATIENT WOKE AND O2 SATURATION REBOUNDED. IT WAS REPORTED THAT THE CUFF TO THE OLD TUBE WAS FOUND TO BE ASYMMETRICAL UPON VISUALLY INSPECTING. THE CUSTOMER NOTED THAT THE ASYMMETRY OF THE CUFF ALLOWED FOOD TO PASS THE WRONG WAY CAUSING TUBE DISCOLORATION. THERE WERE NO FURTHER REPORTED ADVERSE EFFECTS.

  Patient problems: Cyanosis; Diaphoresis; Low Oxygen Saturation; Pallor; Respiratory Distress

  MAUDE report 9814090 ↗

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.