Halyard 46037Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10680651460377), received between Apr 14, 2020 and May 15, 2020 — classified as 2 malfunctions.

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

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 15, 2020Break; Break

  AN FDA MEDWATCH / FDA USER FACILITY REPORT # (B)(4) WAS RECEIVED AND THE FOLLOWING INFORMATION WAS PROVIDED: INCIDENT #1: REPORTS "IN THE FIRST EVENT, THE DISTAL END OF AN NG TUBE, MEASURING APPROXIMATELY 2.5 INCHES, WAS FOUND IN A PATIENT'S STOOL. THE REMAINING PART OF THE NG TUBE THAT WAS STILL IN THE PATIENT WAS SUBSEQUENTLY REMOVED. AN X-RAY SHOWED NO EVIDENCE OF ANY RADIOPAQUE FRAGMENT THAT WAS RETAINED IN THE PATIENT. IT IS UNCLEAR WHEN EXACTLY THE TIP OF THE NG TUBE BROKE OFF. EVENT DATE: (B)(6) 2020.

  Patient problems: Foreign Body In Patient

  MAUDE report 10063759 ↗
• MalfunctionApr 14, 2020Material Deformation

  WE HAVE HAD TWO EVENTS THIS WEEK. IN THE FIRST EVENT, THE DISTAL END OF AN NG TUBE, MEASURING APPROXIMATELY 2.5 INCHES, WAS FOUND IN A PATIENT'S STOOL. THE REMAINING PART OF THE NG TUBE THAT WAS STILL IN THE PATIENT WAS SUBSEQUENTLY REMOVED. AN X-RAY SHOWED NO EVIDENCE OF ANY RADIOPAQUE FRAGMENT THAT WAS RETAINED IN THE PATIENT. IT IS UNCLEAR WHEN EXACTLY THE TIP OF THE NG TUBE BROKE OFF. IN THE SECOND EVENT INVOLVING A DIFFERENT PATIENT, THE NG TUBE WAS CLOGGED AND THEN REMOVED. THE NG TUBE WAS NOT FRAGMENTED INSIDE THE PATIENT, AS IN THE FIRST CASE, BUT THERE WAS SIMILAR DAMAGE TO THE TUBE SEEN UPON INSPECTION. A SEGMENT OF THE NG TUBE HAD BALLOONED OUT BUT DID NOT BREAK APART.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9956928 ↗