MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; SET,PUMP,1000ML BAG,ENFIT,MEDLINE

Catalog Number	ENFIT70552
Medical Device Problem Codes	Material Fragmentation (1261); Leak/Splash (1354); Melted (1385)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/08/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility, on (b)(6) 2025, "tube feed bag was connected to g -tube.It was leaking not long after connection and when disconnected it was noticed to have cracked and melted into the g - tube, causing a patient to have to receive intervention and his g -tube emergently replaced.Per the facility, "bits of plastic that cracked off from tube feed connector" got inside the patient."patient is doing well.".
Additional Manufacturer Narrative
According to the facility, on (b)(6) 2025, "tube feed bag was connected to g -tube.It was leaking not long after connection and when disconnected it was noticed to have cracked and melted into the g - tube, causing a patient to have to receive intervention and his g -tube emergently replaced.Per the facility, "bits of plastic that cracked off from tube feed connector" got inside the patient."patient is doing well." it has been determined that the reported event caused or contributed 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.

• Common Device Name: SET,PUMP,1000ML BAG,ENFIT,MEDLINE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; 3 lakes dr; northfield 60093
• Manufacturer Contact: alyssa reasner ; 3 lakes dr; northfield 60093
• MDR Report Key: 23015853
• Report Number: 1417592-2025-00460
• Device Sequence Number: 13148225
• Product Code: PIF
• UDI-Device Identifier: 10884389190333
• UDI-Public: 10884389190333
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• 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): 09/10/2025

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?: No
• Device Catalogue Number: ENFIT70552
• Device Lot Number: 96925010001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 09/10/2025
• 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: Required Intervention; Other
• Patient Age: 10 YR
• Patient Sex: Unknown
• Patient Weight: 19 KG