Bivona SU15CN40NSB189SRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10351688848161), received between Feb 28, 2017 and Feb 28, 2017 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Break” (4 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.

• MalfunctionFeb 28, 2017Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT A PORTEX® BIVONA® CUSTOM NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE EYELET BROKE, THE TRACHEOSTOMY TUBE FELL APART, AND THE TUBE FELL OUT. THE INCIDENT WAS OBSERVED BY THE PATIENT'S MOTHER AND THE HOME HEALTHCARE NURSE. THE TRACHEOSTOMY TUBE WAS IN USE FOR 6-8 WEEKS BEFORE THE EYELET BROKE. IT WAS NOTED THAT VELCRO TIES WERE USED TO HOLD THE TRACHEOSTOMY TUBE IN PLACE. THE TIES WERE CHANGED ONCE A DAY AFTER THE PATIENT WAS BATHED. THE TRACHEOSTOMY TUBE WAS FIXED BY THE PATIENT'S MOTHER BY "SEWING IT" TO ADDRESS THE ISSUE. NO PATIENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-00581, 3012307300-2017-00582, AND 3012307300-2017-00583.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6365445 ↗
• MalfunctionFeb 28, 2017Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT A PORTEX® BIVONA® CUSTOM NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE EYELET BROKE, THE TRACHEOSTOMY TUBE FELL APART, AND THE TUBE FELL OUT. THE INCIDENT WAS OBSERVED BY THE PATIENT'S MOTHER AND THE HOME HEALTHCARE NURSE. THE TRACHEOSTOMY TUBE WAS IN USE FOR 6-8 WEEKS BEFORE THE EYELET BROKE. IT WAS NOTED THAT VELCRO TIES WERE USED TO HOLD THE TRACHEOSTOMY TUBE IN PLACE. THE TIES WERE CHANGED ONCE A DAY AFTER THE PATIENT WAS BATHED. THE TRACHEOSTOMY TUBE WAS REPLACED WITH A PREVIOUSLY USED TUBE TO ADDRESS THE ISSUE. NO PATIENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-00581, 3012307300-2017-00583, AND 3012307300-2017-00584.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6365443 ↗
• MalfunctionFeb 28, 2017Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT A PORTEX® BIVONA® CUSTOM NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE EYELET BROKE, THE TRACHEOSTOMY TUBE FELL APART, AND THE TUBE FELL OUT. THE INCIDENT WAS OBSERVED BY THE PATIENT'S MOTHER AND THE HOME HEALTHCARE NURSE. THE TRACHEOSTOMY TUBE WAS IN USE FOR 6-8 WEEKS BEFORE THE EYELET BROKE. IT WAS NOTED THAT VELCRO TIES WERE USED TO HOLD THE TRACHEOSTOMY TUBE IN PLACE. THE TIES WERE CHANGED ONCE A DAY AFTER THE PATIENT WAS BATHED. THE TRACHEOSTOMY TUBE WAS FIXED BY THE PATIENT'S MOTHER BY "SEWING IT" TO ADDRESS THE ISSUE. NO PATIENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-00581, 3012307300-2017-00582, AND 3012307300-2017-00584.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6365442 ↗
• MalfunctionFeb 28, 2017Break; Material Integrity Problem; Break; Material Integrity Problem

  IT WAS REPORTED THAT A PORTEX® BIVONA® CUSTOM NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBE EYELET BROKE, THE TRACHEOSTOMY TUBE FELL APART, AND THE TUBE FELL OUT. THE INCIDENT WAS OBSERVED BY THE PATIENT'S MOTHER AND THE HOME HEALTHCARE NURSE. THE TRACHEOSTOMY TUBE WAS IN USE FOR 6-8 WEEKS BEFORE THE EYELET BROKE. IT WAS NOTED THAT VELCRO TIES WERE USED TO HOLD THE TRACHEOSTOMY TUBE IN PLACE. THE TIES WERE CHANGED ONCE A DAY AFTER THE PATIENT WAS BATHED. THE TRACHEOSTOMY TUBE WAS REPLACED WITH A PREVIOUSLY USED TUBE TO ADDRESS THE ISSUE. NO PATIENT INJURY WAS REPORTED. SEE MFR: 3012307300-2017-00582, 3012307300-2017-00583, AND 3012307300-2017-00584.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6365439 ↗

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.