MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP MEDLINE; SET,GVTY FEEDING BG 1000ML,ENFIT,MEDLINE

Catalog Number	ENFIT70503
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that "gravity bag tubing was leaking at connection to ng tube.Tried tightening tube connection but continued leaking & switched feed to new bag".It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
Gravity bag tubing was leaking at connection to ng tube.

• Brand Name: MEDLINE
• Common Device Name: SET,GVTY FEEDING BG 1000ML,ENFIT,MEDLINE
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 24716102
• Report Number: 1417592-2026-00292
• Device Sequence Number: 5763672
• Product Code: KNT
• UDI-Device Identifier: 10884389190326
• UDI-Public: 10884389190326
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K150286
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: ENFIT70503
• Device Lot Number: 96925010006
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/30/2026
• Date Device Manufactured: 01/01/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown