Halyard 46094Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10680651460940), received between Oct 28, 2020 and Feb 14, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Malposition of Device” (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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 14, 2024Malposition of Device; Malposition of Device

  IT WAS REPORTED, ¿INCORRECT INSERTION INTO LUNG OCCURRED. VERY SMALL AMOUNT OF NUTRITION WAS MIS-ADMINISTERED INTO LUNG. THE MONITOR SHOWED THE INCORRECT INSERTION, BUT IT WAS NOT NOTICED DURING THE INSERTION AND ALSO FROM X-RAY DATA AFTER INSERTION.¿ NO MEDICAL INTERVENTIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18705519 ↗
• InjuryFeb 4, 2021Malposition of Device; Sharp Edges; Malposition of Device; Sharp Edges

  IT WAS REPORTED THAT TWO GASTRIC MUCOSA PERFORATIONS OCCURRED DURING INSERTION OF THE NG TUBE. THE PERFORATIONS WERE LOCATED "AROUND UPPER STOMACH POSTERIOR WALL" AND WERE REPAIRED BY GASTRIC CLIPS. THE NG TUBE WAS REMOVED BY ENDOSCOPE. IT WAS NOTED THAT "DURING THE INSERTION, PASSING CARDIAC ORIFICE WAS DIFFICULT BUT LATER ON IT WENT THROUGH AND ADVANCE TO JEJUNUM." THE DOCTOR POINTED OUT THE TUBE HAD A "SLIGHTLY SHARP END." ONE WEEK AFTER THE EVENT, AN ALTERNATIVE TUBE WAS INSERTED UNDER ENDOSCOPE AND THE TWO PERFORATIONS WERE NOTED TO HAVE "RECOVERED." ADDITIONAL INFORMATION RECEIVED VIA INTERVIEW WITH A PHYSICIAN ON 29-JAN-2021 INCLUDED PATIENT INFORMATION AND THAT THE EVENT WAS "MOST LIKELY DUE TO PATIENT ANATOMICAL FEATURES."

  Patient problems: Perforation

  MAUDE report 11278153 ↗
• MalfunctionOct 28, 2020Difficult to Insert; Material Puncture/Hole; Difficult to Insert; Material Puncture/Hole

  IT WAS REPORTED THAT DURING INSERTION OF THE NASOGASTRIC (NG) TUBE, "RESISTANCE WAS FELT AT AROUND CARDIA AND IT WAS DIFFICULT TO INSERT THE TUBE. THE USER TRIED TO MOVE THE TUBE IN AND OUT A FEW TIMES BENDING THE TUBE. THE TUBE WAS TORN AND STYLET CAME OUT FROM THE TEAR ON THE TUBE WHILE THE TUBE WAS PLACED IN THE PATIENT. NO PATIENT INJURY REPORTED." PER ADDITIONAL INFORMATION RECEIVED ON 13 OCT 2020, THE TUBE WAS NOT FLUSHED WITH WATER WHEN REMOVING THE STYLET. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10751696 ↗