AVANOS 44109Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00350770441092), received between Dec 31, 2020 and Jan 5, 2023 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (2 reports).

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

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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. May 31, 2024Open, Classified

   The IFU was missing some risk information requested by another country to be contained in the IFU pertaining to potential complications.

   Z-2422-2024 · Root cause: Error in labeling · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED, A PATIENT HAD A HALYARD GASTRIC-JEJUNAL FEEDING TUBE (GJ TUBE), 18FR 1.7CM 30CM TUBE THAT ¿BROKE OFF¿. (B)(6)2022, TO ¿GRAB¿ THE BROKEN TUBE FROM THE SMALL INTESTINE, WHERE IT WAS REPLACED BY THE DOCTOR. THERE WAS NO REPORTED INJURY TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED (B)(6)2022 REPORTED, INTERVENTIONAL RADIOLOGY (IR) PLACED THE GJ TUBE ON (B)(6)2022 ; THE TUBE WAS BEING REPLACED WHEN THE ¿BREAK¿ WAS DISCOVERED. AN ENDOSCOPY, WITH GENERAL ANESTHESIA, WAS PERFORMED TO REMOVE THE BROKEN GJ TUBE AND TO PLACE THE NEW ONE. THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 16104772 ↗
• MalfunctionFeb 3, 2021Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS INITIALLY REPORTED THAT THE DEVICE WAS CHANGED DUE TO LEAKING. THE DEVICE WAS RETURNED AND ON (B)(6) 2021 IT WAS IDENTIFIED THAT THE INNER WALL OF THE TUBING WHICH SEPARATES THE JEJUNAL AND GASTRIC LUMENS HAD TORN, ALLOWING FOR INNER LUMEN CROSSOVER. ADDITIONAL INFORMATION RECEIVED 21-JAN-2021 INDICATED THERE WAS NO PATIENT HARM. NO FURTHER DETAILS WERE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 11276010 ↗
• MalfunctionDec 31, 2020Fluid/Blood Leak; Material Split, Cut or Torn; Fluid/Blood Leak; Material Split, Cut or Torn

  IT WAS REPORTED THAT THE FEEDING TUBE WAS CHANGED DUE TO LEAKING. INJECTION OF CONTRAST BY RADIOLOGIST VIA JEJUNAL PORT SHOWED CONTRAST ENTERING THE STOMACH. THE TUBE WAS FOUND TO BE SPLIT. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 11102567 ↗