Argyle 461008ERecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521547230), received between Mar 18, 2020 and May 13, 2020 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Crack” (2 reports).

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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2020Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED THAT THEY OPENED A NEW TUBE BOX AND THERE WERE THREE DEFECTIVE TUBES INSIDE. THE TUBES WERE BENT. THE ISSUE WAS DISCOVERED BEFORE USE.

  Patient problems: No Patient Involvement

  MAUDE report 10052177 ↗
• MalfunctionMay 7, 2020Material Twisted/Bent; Material Twisted/Bent

  THE CUSTOMER REPORTED THAT THE FEEDING TUBE WAS KINKED AT THE DISTAL END. THE TUBE WAS BENT AND VERY DIFFICULT TO INSTALL IN THE BABY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10033571 ↗
• MalfunctionMar 27, 2020Crack; Fluid/Blood Leak; Crack; Fluid/Blood Leak

  THE CUSTOMER REPORTED THAT THE INFANT WAS RECEIVING NG TUBE FEEDING. UPON ASSESSMENT, THE RN NOTICED THAT THE CRIB SHEET WAS WET AND THERE WAS LEAKING AT THE HUB OF THE NG TUBE. UPON INSPECTION, THE NG TUBE HAD A CRACKED AT THE HUB. THE DEVICE WAS REMOVED AND PLACED WITH A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9889516 ↗
• MalfunctionMar 19, 2020Crack; Leak/Splash

  THE INFANT WAS RECEIVING NG TUBE FEEDING. UPON ASSESSMENT RN NOTICED CRIB SHEET WAS WET AND LEAKING AT HUB OF NG TUBE. UPON INSPECTION NOTICED CRACK AT HUB. NG TUBE WAS REMOVED AND NEW ONE PLACED. BREAST MILK THAT WAS IN SYRINGE WAS DISCARDED DUE TO RISK FOR INFECTION ON PREMATURE INFANT.

  Patient problems: Unspecified Infection

  MAUDE report 9852863 ↗
• MalfunctionMar 18, 2020Device Markings/Labelling Problem

  RN OPENED 5FR NG TUBE FOR PLACEMENT IN NICU PATIENT. UPON INSPECTION FOR MEASUREMENT, RN NOTED THAT THE TUBE WAS MISSING THE PRINTED MARKINGS ON THE TUBE. TUBING AND PACKAGING WAS SAVED AND NEW TUBE WAS OBTAINED AND USED. THE DEVICE WAS NEVER USED ON PATIENT. IT WAS FOUND PRIOR TO USE ON INFANT.

  Patient problems: No Patient Involvement

  MAUDE report 9847361 ↗