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

Model Number	INF0500-E
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to mmdg for evaluation.A dhr review was not completed because the device lot number was not provided.Because the device was not returned, mmd has been unable to investigate or confirm 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 set would not deliver formula.Mmd did follow up with the initial reporter.They did not report any adverse effect to the patient.They also stated they did not have any additional information.(b)(4).

• Brand Name: BAG SET, 500ML, ENFITCONNECTOR
• Common Device Name: ENTERAL FEEDING SET
• Manufacturer (Section D): MOOG MEDICAL DEVICES; 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: 24250807
• Report Number: 1722139-2026-00047
• Device Sequence Number: 21230840
• 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: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 01/09/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Initial Report FDA Received Date: 02/03/2026
• 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 Sex: Unknown