MAUDE Adverse Event Report: MOOG MEDICAL DEVICES GROUP BAG SET, 500ML, ENFITCONNECTOR; ENTERAL FEEDING SET

Model Number	INF0500-E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to mmd for evaluation.A dhr was completed and no non-conformances were found.Because the device was not returned to mmd an investigation could not be completed.This report will be updated if the device is returned to mmdg.
Event or Problem Description
The initial reporter states that the bag had been dropped and that it caused a home in the side seam of the bag.They stated that they were able to start the feeding with a new set when they returned home, but that being away from home did result in a two and a half hour delay of therapy.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).

• 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 ; 8012641001
• MDR Report Key: 22440524
• Report Number: 1722139-2025-00391
• Device Sequence Number: 4745803
• 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): 06/09/2025

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: CF2501707
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 07/08/2025
• 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: 14 YR
• Patient Sex: Male