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
Update to e1.After further investigation, it has been determined that additional reporter and facility contact information was identified, including the complainant (b)(6), email address (b)(6) and (b)(6), hospital (b)(6), located at (b)(6).If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
According to the facility on (b)(6) 2026, the "entraflo 1000 ml gravity feeding set was noted to be leaking at the distal end of the tubing at approximately 15:45 during the feed".
Additional Manufacturer Narrative
According to the facility on (b)(6) 2026, the "entraflo 1000 ml gravity feeding set was noted to be leaking at the distal end of the tubing at approximately 15:45 during the feed".It has been determined that the reported event could cause or contribute to serious injury requiring medical intervention, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

• Brand Name: MEDLINE
• Common Device Name: SET,GVTY FEEDING BG 1000ML,ENFIT,MEDLINE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes dr; northfield IL 60093
• Manufacturer Contact: gavin-ainsley nadong ; three lakes dr; northfield, IL 60093
• MDR Report Key: 24757925
• Report Number: 1417592-2026-00351
• Device Sequence Number: 21123501
• Product Code: KNT
• UDI-Device Identifier: 10884389190326
• UDI-Public: 10884389190326
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Followup
• Report Date (Section B): 04/03/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ENFIT70503
• Device Lot Number: 96925010006
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 04/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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