AVANOS 42-9361Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00350770460888), received between Jun 8, 2021 and Jun 8, 2021 — classified as 1 malfunction.

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

• MalfunctionJun 8, 2021Stretched; Stretched

  IT WAS REPORTED THE PATIENT HAD A PANIC ATTACK AND FELT LIKE HE COULD NOT BREATHE FOLLOWING ADMINISTRATION OF MEDICATION THROUGH THE NG [NASOGASTRIC] TUBE. THE PATIENT WENT TO DAYCARE IN THE AFTERNOON AND EXPLAINED HOW HE FELT LIKE HE COULD NOT BREATHE AND HIS THROAT FELT FUNNY. THE NG TUBE WAS REMOVED ON (B)(6) 2021 AS IT WAS NO LONGER REQUIRED FOR MAGNESIUM AND CALCIUM SUPPLEMENTS, AND THE NG TUBE WAS FOUND TO HAVE AN "AIR BUBBLE." ACCORDING TO THE CUSTOMER, THE "BUBBLE" WOULD HAVE SAT IN THE PATIENT'S THROAT. ADDITIONAL INFORMATION RECEIVED 25-MAY-2021 INDICATED "PATIENT COMPLAINED OF FEELING BLOCKAGE IN THROAT WHEN MEDICATIONS ADMINISTERED AT HOME. NG TUBE NO LONGER REQUIRED WHEN ATTENDED HOSPITAL FOR ROUTINE APPOINTMENT AND THEREFORE REMOVED. ON REMOVAL IT BECAME APPARENT THAT A SECTION OF THE TUBE WAS DISTORTED, AS IF IT HAD INFLATED. PATIENT DISTRESS WHEN MEDICATIONS DELIVERED, FELT UNABLE TO BREATHE."

  Patient problems: Airway Obstruction; Discomfort

  MAUDE report 11959015 ↗