Halyard 46042Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10680651460421), received between Jan 9, 2020 and Dec 24, 2020 — classified as 3 malfunctions.

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

• MalfunctionDec 24, 2020Material Puncture/Hole; Device Damaged Prior to Receipt by User

  NASOGASTRIC TUBE WAS DELIVERED TO A PATIENT'S HOME. UPON OPENING THE BAG THAT CONTAINED THE TUBE, PATIENT'S MOTHER DISCOVERED HOLES ON BOTH ENDS OF THE TUBE NEAR THE PORTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11071839 ↗
• MalfunctionMay 28, 2020Break; Break

  IT WAS REPORTED THE DEVICE BROKE AND WAS RETAINED INSIDE OF THE PATIENT'S GASTRO-INTESTINAL (GI) TRACT. THE PATIENT WAS TAKEN TO THE GI LAB FOR RETRIEVAL OF THE BROKEN DEVICE SEGMENTS THAT WAS INSIDE THE STOMACH. THERE WAS NO REPORTED INJURY. ADDITIONAL INFORMATION RECEIVED 08-MAY-2020 STATED THE PLACEMENT WAS ACTUALLY NASOJEJUNAL. THE INCIDENT WAS UNCOVERED DURING A MORNING X-RAY EXAM. THE DEVICE WAS PLACED ON (B)(6) 2020 AND REMOVED ON (B)(6) 2020. THE PATIENT WAS TAKEN TO ENDOSCOPY FOR REMOVAL OF BOTH PIECES. THE DEVICE WAS PLACED TO INITIATE TUBE FEEDS ON (B)(6) 2020. THE FEEDS WERE HELD, AND THE PATIENT WAS NPO (NOTHING BY MOUTH) FROM (B)(6) 2020 UNTIL FEEDS WERE RESUMED AGAIN ON (B)(6) 2020. ON (B)(6) 2020 AN X-RAY NOTED THE DEVICE SEPARATION. THERE WERE NO ORAL (PO) OR CRUSHED MEDICATIONS ADMINISTERED. THE PATIENT ONLY RECEIVED SIMILAC PRO ADV 24 CAL. THERE WAS NO DOCUMENTED HISTORY OF THE DEVICE CLOGGING. THE PATIENT RECEIVED DAILY CHEST X-RAYS AND THE LAST DATE THE NASOJEJUNAL TUBE (NJT) WAS VISIBLE ON X-RAY WAS (B)(6) 2020. AT THAT TIME THE X-RAY TUBE SHOWED "GOOD POSITION, NO BREAKAGE." THERE WAS NO CHANGE DOCUMENTED IN PLACEMENT AT THE NOSTRIL.

  Patient problems: Foreign Body In Patient

  MAUDE report 10097254 ↗
• MalfunctionJan 9, 2020Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT A CORFLO NG TUBE ¿BROKE IN THE PATIENT." THE CUSTOMER STATED, "IT LOOKS TO ME LIKE THE TUBING EXPANDED IN ONE LOCATION." NO PATIENT INJURY REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9568498 ↗