Infinity 500 mL Feeding Bag Set with Enfit Connector INF0500-ERecalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10814844001522), received between Apr 20, 2023 and Aug 11, 2026 — classified as 6 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2026Free or Unrestricted Flow

  The Initial Reporter states that the bag sets were free flowing. They reported that they are priming manually because the pump is too slow, and that after priming manually the tubing will start to free flow. There is concern the the in-line occluder is being broken and resulting in the formula leaking. MMD followed up with the Initial Reporter. They stated that the patient had not had any adverse effects due to the complaint. No additional information was provided. "[Complaint: (b)(4)]".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50212991 ↗
• MalfunctionApr 6, 2026Free or Unrestricted Flow

  THE INITIAL REPORTER STATES THAT THE BAG SETS WERE FREE FLOWING. THEY STATED THAT THE TUBING WAS BENT AND THEY THE DEVICE "KEPT RUNNING" DUE TO THIS ISSUE. MMD FOLLOWED UP WITH THE INITIAL REPORTER. THEY STATED THAT THE PATIENT HAD NOT HAD ANY ADVERSE EFFECTS DUE TO THE COMPLAINT. NO ADDITIONAL INFORMATION WAS PROVIDED. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24793431 ↗
• MalfunctionFeb 3, 2026Failure to Deliver

  THE INITIAL REPORTER STATES THAT THE BAG SET WOULD NOT DELIVER FORMULA. THEY STATED THAT THEY HAD THIS HAPPEN WITH MULTIPLE BAGS FROM THIS LOT. THE INITIAL REPORTER STATED THAT THE PATIENT HAD LOST WEIGHT AND THEY FELT IT WAS DUE TO THIS ISSUE. THEY DID NOT PROVIDE ANY ADDITIONAL INFORMATION. [(B)(4)].

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250808 ↗
• MalfunctionFeb 3, 2026Failure to Deliver

  THE INITIAL REPORTER STATES THAT THE BAG SET WOULD NOT DELIVER FORMULA. MMD DID FOLLOW UP WITH THE INITIAL REPORTER. THEY DID NOT REPORT ANY ADVERSE EFFECT TO THE PATIENT. THEY ALSO STATED THEY DID NOT HAVE ANY ADDITIONAL INFORMATION. (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24250807 ↗
• MalfunctionJul 8, 2025Leak/Splash; Leak/Splash

  THE INITIAL REPORTER STATES THAT THE BAG HAD BEEN DROPPED AND THAT IT CAUSED A HOME IN THE SIDE SEAM OF THE BAG. THEY STATED THAT THEY WERE ABLE TO START THE FEEDING WITH A NEW SET WHEN THEY RETURNED HOME, BUT THAT BEING AWAY FROM HOME DID RESULT IN A TWO AND A HALF HOUR DELAY OF THERAPY. MMD FOLLOWED UP WITH THE INITIAL REPORTER. THEY STATED THAT THE PATIENT HAD NOT HAD ANY ADVERSE EFFECTS DUE TO THE COMPLAINT. NO ADDITIONAL INFORMATION WAS PROVIDED. COMPLAINT-(B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22440524 ↗
• MalfunctionApr 20, 2023Leak/Splash; Defective Device

  THE NURSE CONNECTED THE ENTERALITE FEEDING BAG TO PATIENT AND NOTED THERE WAS LEAKING AROUND THE CONNECTIONS SITE. SHE TRIED TO CONNECT TO BOTH AN NJ AND A G-TUBE WITH LEAKING AT BOTH. 2 ADDITIONAL BAGS FROM THE STORAGE ROOM WERE TRIED AND THEY ALSO LEAKED. IT WAS NOTED THAT ALL THREE BAGS CAME FROM THE SAME LOT NUMBER. THE NURSE WENT TO ANOTHER FLOOR AND OBTAINED A BAG FROM A DIFFERENT LOT NUMBER AND WAS ABLE TO SUCCESSFULLY PROVIDE FEEDINGS TO THE PATIENT WITHOUT LEAKAGE.

  Patient problems: Insufficient Information

  MAUDE report 16775558 ↗