Halyard 95475Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651954753), received between May 9, 2018 and May 9, 2018 — classified as 1 injury.

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.

• InjuryMay 9, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED STATING THE PATIENT ENDED UP WITH A PERFORATION FROM THE DEVICE. DURING INSERTION THE DEVICE DID NOT ADVANCE FAR SO THE PHYSICIAN CUT THE TUBE SHORTER, TO ABOUT 7 CM, AND IT PERFORATED THE PATIENT'S BOWEL. THE PHYSICIAN USED A STIFF GLIDE AND AN AMPLATZ (WITH A 3.5 CM SOFT TIP) FOR THE EXCHANGE. IT WAS ALSO A DIRECT STICK INTO THE JEJUNUM, NOT A GASTROSTOMY TO JEJUNUM INSERTION. THE PATIENT HAD TO HAVE EMERGENCY SURGERY BECAUSE THE PERFORATION WAS NOT FOUND UNTIL THE NEXT DAY. THE PATIENT WAS IN PAIN, EXPERIENCED SHORTNESS OF BREATH (SOB) AND EXPERIENCED SHOULDER PAIN/CHEST PAIN. THE PATIENT WAS REPORTED TO BE DOING BETTER SINCE SURGERY AND THE DEVICE WAS REPLACED WITH JUST A RED RUBBER CATHETER. THE PATIENT HAD A T-TUBE IN PLACE PRIOR TO THE EVENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Bowel Perforation; Chest Pain; Dyspnea; Respiratory Distress

  MAUDE report 7498191 ↗