MAUDE Adverse Event Report: Moog Medical Devices Group Bag Set, 500ML, Enfitconnector; Enteral Feeding Set

Model Number	INF0500-E
Medical Device Problem Code	Free or Unrestricted Flow (2945)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter states that the bag sets were free flowing.They reported that they are priming manually because the pump is too slow, and that after priming manually the tubing will start to free flow.There is concern the the in-line occluder is being broken and resulting in the formula leaking.Mmd followed up with the initial reporter.They stated that the patient had not had any adverse effects due to the complaint.No additional information was provided."[complaint: (b)(4)]".
Additional Manufacturer Narrative
The device was not returned to mmd for evaluation.A dhr was not completed because the device lot number was not provided.Because the device was not returned, mmd has been unable to investigate the complaint.This report will be updated if the device is returned to mmd.

• Brand Name: Bag Set, 500ML, Enfitconnector
• Common Device Name: Enteral Feeding Set
• Manufacturer (Section D): Moog Medical Devices Group; 4314 zevex park lane; salt lake city UT 84123
• Manufacturer (Section G): Moog Medical Devices Group, SRL; coyol free zone and; business park; alajuela, 20113 ; CS 20113
• Manufacturer Contact: kristin egelhoff ; 4314 zevex park lane; salt lake city, UT 84123 ; +1(801)264-1001
• MDR Report Key: 50212991
• Report Number: 1722139-2026-00212
• Device Sequence Number: 14977056
• Product Code: PIO
• UDI-Device Identifier: 10814844001522
• UDI-Public: 10814844001522
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142539
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/25/2026

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: Other
• Device Model Number: INF0500-E
• Device Catalogue Number: INF0500-E
• Device Lot Number: not provided
• 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: 06/25/2026
• Initial Report FDA Received Date: 08/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (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
• Patient Age: 37 YR
• Patient Sex: Unknown