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

Catalog Number	ENFIT70503
Medical Device Problem Codes	Crack (1135); Leak/Splash (1354)
Health Effect - Clinical Code	Feeding Problem (1850)
Date of Event	02/02/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Updated: d4, g1, g2, g6, h2.
Event or Problem Description
Gravity feed bag leaking from connection point between bag and tubing (appears to have tiny cracks in the plastic tip).Bag was used to provide nutrition via enteral feeding of fortified expressed breast.
Additional Manufacturer Narrative
According to the customer, the "gravity feed bag leaking from connection point between bag and tubing (appears to have tiny cracks in the plastic tip.)" per the customer, "bag was used to provide nutrition via enteral feeding of fortified expressed breast [milk]." no additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.No additional information is available.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.
Additional Manufacturer Narrative
Update to d9: is this device available for evaluation.Update to h3: device evaluated by manufacturer.Update to h6: type of investigation (b).Update to h6: investigation findings (c).Update to h6: investigation conclusions (d).

• 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: jessica walter ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 24499453
• Report Number: 1417592-2026-00176
• Device Sequence Number: 10115292
• Product Code: PIF
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/27/2026

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Supplement Date Received by Manufacturer: Not provided; 04/22/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 03/03/2026; 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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