NeoConnect Enteral Extension Set PEXT-60NCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00817584012028), received between Nov 4, 2019 and Oct 21, 2020 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionOct 21, 2020Leak/Splash

  WE ARE REPORTING TWO FAILURES OF THE SAME PRODUCT THAT HAPPENED WITHIN 1 WEEK OF EACH OTHER: ON (B)(6) 2020: THE FEEDING TUBING WAS FOUND TO HAVE LEAKED THE BABY'S FEEDING. AFTER THE FEEDING WAS COMPLETE AND THE PUMP TURNED OFF, THE BABY WAS FUSSY AND ACTING HUNGRY. IT WAS THEN DISCOVERED HIS LINENS SOAKED IN FORMULA UNDER THE TUBING AND NG CONNECTION. SOME FORMULA WAS MANUALLY PUSHED THROUGH THE TUBING AND IT WAS ALL LEAKING OUT OF A CRACK AT THE HUB. THE BABY WAS RE-FED THROUGH NEW TUBING THAT WAS NOT CRACKED OR LEAKING (LOT# 20200227). ON (B)(6) 2020: THE FEEDING TUBE (NEOCONNECT ENTERAL EXTENSION SET WITH ENFIT CONNECTOR LOT:20200110) LEAKED MEDOLAC FEED WHERE IT CONNECTS TO THE PATIENT'S NG TUBE WHEN BEING ADMINISTERED BY PUMP. THE HEALTH CARE PROVIDER CAUGHT THE LEAK EARLY SO ONLY A FEW ML WAS WASTED AND NEW TUBING WAS OBTAINED TO DELIVER THE REMAINDER OF THE PATIENT'S FEED.

  Patient problems: Underdose

  MAUDE report 10711138 ↗
• MalfunctionJul 15, 2020Leak/Splash; Defective Device

  A TOTAL OF 22 DEFECTIVE NEOCONNECT 60" (152 CM) ENFIT EXTENSION SETS (PEXT-60NC) WERE FOUND BETWEEN MAY 18TH AND JUNE 15TH, 2020. THE TUBING SETS WERE FROM 4 DIFFERENT LOT NUMBERS, BUT THE SAME DI/PRODUCT/REFERENCE #S. THE DEFECTIVE LOTS WERE AS FOLLOWS: 20191126, 20191218, 20191230, AND 20200110. THE CAREGIVERS FOUND THE ENFIT FEEDING EXTENSION LEAKING AT THE PATIENT CONNECTION. ALL HAVE BEEN CHECKED TO MAKE SURE THEY WERE SECURED APPROPRIATELY WITH NO "TILTING" OR MISCONNECTION NOTED. ALSO THAT THEY WERE NOT "TOO TIGHT" OR "LOOSE". SOME HAVE BEEN NOTED TO BE CRACKED AT PATIENT SIDE SECUREMENT. ONCE WE HAD 2 EXTENSIONS THAT WERE COMPROMISED, WE IMMEDIATELY NOTIFIED OUR NURSING STAFF TO WATCH FOR OTHERS. BECAUSE OUR STAFF WAS AWARE, THEY HAVE BEEN ABLE TO CATCH THE LEAKS EARLY ON SO INFANTS RECEIVE THEIR FULL CALORIES AS ORDERED. THEY HAVE WORKED WITH MATERIALS TO PULL THOSE LOT NUMBERS AS DEFECTIVE BATCHES HAVE BEEN FOUND. ONLY FOUR PATIENTS ARE INCLUDED IN THIS REPORTS ALTHOUGH THERE WERE MORE AFFECTED. BREAKDOWN OF LOT #'S: 20191126 - 8 TOTAL. 20191218 - 3 TOTAL. 20191230 - 3 TOTAL. 20200110 - 1 TOTAL. UNKNOWN - 7 TOTAL (PACKAGING NOT SAVED BUT CONNECTION/TUBING WAS).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10275436 ↗
• MalfunctionNov 4, 2019Fluid/Blood Leak

  ON (B)(6) 2019 - ON TWO SEPARATE INCIDENCES OCCURRED (IN THE SPAN OF 24 HOURS) FOR PURPLE FEEDING EXTENSION TUBES LEAKING MILK ONTO THE BED AT THE CONNECTION BETWEEN THE END OF THE NG TUBE AND THE FEEDING EXTENSION TUBE. THERE WERE NO CRACKS OR HOLES SEEN IN THE TUBING AND THE CONNECTIONS SEEMED SECURE. THE CAUSE OF BOTH EVENTS ARE UNKNOWN, SO WE ARE TRACKING OCCURENCES TO HELP SPOT TRENDS. ON (B)(6) 2019 - DURING SHIFT HANDOFF AT 0600, INFANT ENFIT FEEDING TUBE ENTERAL EXTENSION SET WAS FOSUND TO BE LEAKING FORMULA AT PATIENT SIDE CONNECTOR WITH A MODERATE AMOUNT OF FORMULA NOTED ON BURP CLOTH. LEAKING WAS NOTED BY BOTH DAY AND NIGHT SHIFT RN'S. FEEDING EXTENSION SET WAS CHANGED AND FEEDING CONTINUED WITHOUT FURTHER LEAKAGE. ON (B)(6) 2019 - FEEDING LEAKING FROM EXTENSION SET. SECOND TIME THIS WEEK. THIS IS A REPLACEMENT PRODUCT DUE TO A BACK ORDER. ON (B)(6) 2019 - FEEDING EXTENSION TUBING LEAKED. ON (B)(6) 2019 - ENFIT FEEDING EXTENSION TUBING LEAKED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9271485 ↗