Halyard 95674Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651956740), received between Oct 12, 2017 and Oct 12, 2017 — classified as 1 malfunction.

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. 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.

• MalfunctionOct 12, 2017Break; Break

  IT WAS REPORTED THAT MEDWATCH, FDA REPORT NUMBER FDA 3500 FORM 5071402, WAS RECEIVED STATING, "PATIENT HAD EXISTING J TUBE INSERTED (B)(6) 2016 IN OUR DEPARTMENT. THE PATIENT WAS ON OUR TABLE FOR REPLACEMENT (B)(6) 2017 AND WE DISCOVERED THAT THE TUBE WAS BROKEN, A SCOUT FILM BEFORE WE START AND THE SCOUT APPEARED TO SHOW A DISCONNECT IN THE CATHETER SUGGESTIVE OF A CATHETER FRACTURE. SURE ENOUGH IT WAS FRACTURED AND THE LARGER DISTAL PORTION (ESSENTIALLY THE WHOLE TUBE EXCEPT FOR A SMALL PORTION WHICH GOES INTO THE STOMACH REMAINED) APPEARED TO HAVE MIGRATED INTO THE LARGE BOWEL. THE PROXIMAL END OF THE G-J TUBE WAS REMOVED OVER THE WIRE, BUT THE BROKEN SECTION DISTALLY STAYED IN THE BOWEL GENERAL SURGERY WAS CONSULTED, BUT UNLIKELY TO HAVE SURGICAL REMOVAL BASED ON NO SHARP EDGES THAT COULD CAUSE PERFORATION." ADDITIONAL INFORMATION RECEIVED 11-OCT-2017 STATED THE USER REPORTED THAT THE PIECE THAT BROKE OFF AND MIGRATED WAS DETERMINED TO NOT BE OF ANY HARM TO THE PATIENT AND SURGICAL INTERVENTION WAS NOT PERFORMED. NO FURTHER INFORMATION IS AVAILABLE ON INCIDENT OR PATIENT STATUS.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6946175 ↗