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

Catalog Number	ENFIT70503
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Event or Problem Description
According to the facility, on (b)(6) 2026, the enfit gravity feed bag cracked at connection site, the connection point to the ng tube, and milk leaked out.
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2026, the enfit gravity feed bag cracked at connection site, the connection point to the ng tube, and milk leaked out.Per the facility, medical treatment was not necessary.Device was being used as intended.No additional information at this time.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.

• 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 2753
• Manufacturer Contact: alyssa reasner ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24744650
• Report Number: 1417592-2026-00329
• Device Sequence Number: 8779937
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/31/2026

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
• 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?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/04/2026
• Initial Report FDA Received Date: 03/31/2026
• 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