Halyard 46029Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651460292), received between May 22, 2020 and May 22, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 16, 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.

• MalfunctionMay 22, 2020Break; Break

  IT WAS REPORTED THAT THE "PATIENT HAD NGT [NASOGASTRIC TUBE] AND TRACHEOSTOMY IN SITU. PATIENT HAD TRACHEOSTOMY CHANGED. DURING THE TRACHEOSTOMY CHANGE, NGT CAME OUT. ON INSPECTION, NGT HAD MISSING TIP THAT APPEARED BALLOON-LIKE AND HALF CUT. MEDICAL TEAM INFORMED. PORTABLE ABDOMINAL X-RAY PERFORMED AND TIP NOTED TO BE VISIBLE INSIDE PATIENT'S STOMACH. DECISION MADE NOT TO MECHANICALLY RETRIEVE TIP. PATIENT WAS NOT HARMED." ADDITIONAL INFORMATION RECEIVED 12-MAY-2020 INDICATED THE NGT WAS IN USE FOR 5 DAYS. THE CUSTOMER STATED "THE TRACHEOSTOMY WOULD NOT HAVE RESULTED IN THE NGT BEING CUT OR BROKEN, AS IT WAS THE DISTAL 5CM THAT WAS BROKEN, AND THIS WAS WELL INSIDE THE PATIENT'S GASTROINTESTINAL CAVITY AT THE TIME OF THE TRACHEOSTOMY CHANGE."

  Patient problems: Foreign Body In Patient

  MAUDE report 10083843 ↗