CORFLO PEG Kit 50-6016E1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10815149021765), received between Mar 5, 2018 and Mar 11, 2020 — classified as 1 injury, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 11, 2020Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT AFTER A PEG TUBE WAS PLACED (AT A DIFFERENT HOSPITAL), THE NURSE ATTEMPTED TO REMOVE VIA TRACTION, BUT THE TUBE SNAPPED, LEAVING THE BUMPER INSIDE THE PATIENT. SURGERY WAS REQUIRED TO REMOVE THE BUMPER FROM THE OLD STOMA TRACT. PER ADDITIONAL INFORMATION RECEIVED 02 MAR 2020, THE PATIENT UNDERWENT SURGERY TO REMOVE PEG FRAGMENTS THAT WERE RETAINED IN STOMA. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR THIS SURGERY FROM (B)(6) 2020 THROUGH (B)(6) 2020, AND THEN WAS READMITTED FROM (B)(6) 2020 THROUGH (B)(6) 2020. THE SURGICAL TEAM INSERTED A FOLEY CATHETER INTO THE STOMA SITE, AND REPORTED THAT IT MUST STAY IN PLACE FOR THREE WEEKS, STARTING (B)(6) 2020. THE PATIENT WILL HAVE THE FOLEY CATHETER REMOVED ON (B)(6) 2020, ALONG WITH POSSIBLE SURGICAL CLOSURE OF THE STOMA. THE PATIENT IS CURRENTLY MEDICALLY IMPROVING BUT STILL COMPLAINING OF PAIN IN THE STOMA AREA. THE PATIENT IS ALSO RECEIVING TREATMENT FOR CONCURRENT PROSTATITUS. NO FURTHER INFORMATION HAS BEEN PROVIDED AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 9817326 ↗
• InjuryMar 5, 2018Break; Break

  IT WAS REPORTED THE PEG END BROKE. IT BROKE DURING THE NIGHT FOLLOWING THE PREVIOUS FEED, THUS THE PREVIOUS FEED AND GASTRIC CONTENTS LEAKED ALL OVER PATIENT. THE DEVICE BROKE AT THE JOINING POINT OF THE Y-CONNECTOR. THE FAMILY MEMBER STATED THE CLAMP WAS ON THE CLAMPED POSITION BUT THIS ALSO FAILED TO STOP BACK-FLOW OF THE GASTRIC CONTENTS. THE GASTRIC CONTENTS CAUSED GASTRIC BURNS TO THE PATIENT'S SKIN. THE BURNED SKINNED IS BEING TREATED WITH DRESSINGS. A NEW CLAMP END WAS PLACED ON THE DEVICE. ADDITIONAL INFORMATION RECEIVED 21-FEB-2018 STATED THE PATIENT HAD A 16 FRENCH CORFLO PEG PLACED IN (B)(6) 2017. THE PEG-Y END SNAPPED OFF OVERNIGHT ON (B)(6). ALTHOUGH THE CLAMP WAS CLOSED, IT FAILED TO STOP THE STOMACH CONTENTS FROM LEAKING ONTO THE PATIENTS SKIN FROM THE PEG TUBE. THE PATIENT WAS UNABLE TO COMMUNICATE AND AS THE INCIDENT WAS OVERNIGHT THE SKIN EXPOSURE TO STOMACH ACID RESULTED IN A 2ND DEGREE BURN TO THE SKIN. THE PATIENT WAS TREATED IN THE ACCIDENT AND EMERGENCY DEPARTMENT (A&E). THE BURN WAS TOO SERIOUS TO TREAT LOCALLY. INITIALLY IT WAS THOUGHT THAT THE PATIENT WOULD NEED A SKIN GRAFT, ALTHOUGH THIS HAS NOT OCCURRED. THE PATIENT IS NOW BEING TREATED WITH DRESSINGS A

  Patient problems: Burn(s)

  MAUDE report 7313096 ↗