MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP BAG SET, 0500ML, 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	03/11/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to mmd for evaluation.A dhr was completed and no non-conformance's were found.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.
Event or Problem Description
The initial reporter states that the bag sets were free flowing.They stated that the tubing was bent and the device "kept running" due to this issue.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.(b)(4).
Event or Problem Description
The initial reporter states that the bag sets were free flowing.They stated that the tubing was bent and they the device "kept running" due to this issue.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.(b)(4).
Additional Manufacturer Narrative
The device was returned to mmd for evaluation.A dhr was completed and no non-conformances were found.When the device was returned to mmd for investigation, the in line occluder in the tubing was bent and did exhibit free flow behavior.During the investigation the bend in the in line occluder was corrected and the set was tested again, at which point it operated as expected and did not free flow.The cause of complaint appears to be mishandling of the device.

• Brand Name: BAG SET, 0500ML, 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 ; 8012641001
• MDR Report Key: 24793431
• Report Number: 1722139-2026-00102
• Device Sequence Number: 8858902
• Product Code: PIO
• UDI-Device Identifier: 10814844001522
• UDI-Public: 10814844001522
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: CF2527420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2026
• Supplement Date Received by Manufacturer: 03/11/2026
• Initial Report FDA Received Date: 04/06/2026
• Supplement Report FDA Received Date: 04/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2025
• 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 Sex: Unknown