Halyard 46050Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651460506), received between Dec 27, 2019 and Dec 27, 2019 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Perforation” (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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 27, 2019Material Perforation; Material Perforation

  AN FDA USER FACILITY REPORT, # (B)(4), WAS RECEIVED ON 02-DEC-2019, AND THE FOLLOWING INFORMATION WAS PROVIDED: PATIENT'S NASOGASTRIC TUBE BECAME CLOGGED WITH BACLOFEN DOSE. THROUGH TROUBLESHOOTING, REPOSITIONING, AND THE USE OF COCA-COLA, THE TUBE BEGAN TO FLUSH EASILY. ENTERAL LORAZEPAM WAS ADMINISTERED WITHOUT ISSUE THREE HOURS LATER. AT MIDNIGHT A CHEST X-RAY WAS OBTAINED TO ASSESS PATIENT LUNG FIELDS DUE TO DIFFICULTY KEEPING PATIENT'S OXYGEN SATURATIONS UP. THE X-RAY SHOWED A 1:1 SEGMENTAL DEFECT IN THE INDWELLING FEEDING TUBE. THERE WAS A BREAK/DISCONTINUITY JUST BEYOND THE GASTROESOPHAGEAL (GE) JUNCTION. THE DISTAL TUBE AND TIP WERE WITHIN THE PATIENT'S STOMACH. WHEN THE FEEDING TUBE WAS PULLED OUT, IT WAS ALL IN ONE PIECE WITH A CLEAR PORTION OF LARGER PERFORATION. THE TUBE WAS SAVED AND PHOTOS PROVIDED. PATIENT DID NOT EXPERIENCE HARM BUT DID HAVE TO HAVE THE TUBING REPLACED. PATIENT WAS DISCHARGED ON (B)(6) 2019. ADDITIONAL INFORMATION RECEIVED 13-DEC-2019 STATED [WE] CANNOT CONFIRM HOW LONG THE NASOGASTRIC (NG) TUBE WAS IN PLACE. THERE WAS NO LOT NUMBER. WE DON¿T BELIEVE ANY HARM OCCURRED AS THE PATIENT WAS DISCHARGED ON (B)(6) 2019, BUT TUBE HAD TO BE REPLACED. DATE OF

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9523211 ↗