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	01/07/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned to mmdg for evaluation.A dhr review was completed and found no non-conformances.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.They stated that they had this happen with multiple bags from this lot.The initial reporter stated that the patient had lost weight and they felt it was due to this issue.They did not provide any additional information.[(b)(4)].
Additional Manufacturer Narrative
The device was returned to mmd for evaluation.A dhr review was completed and found no non-conformances.When the device was returned for this complaint, it was from a different product line and lot number.The device that was returned to mmd operated as expected.Mmd could not replicate or confirm the reported complaint.Based on this information, an mdr may not have been required.
Event or Problem Description
The initial reporter states that the bag set would not deliver formula.They stated that they had this happen with multiple bags from this lot.The initial reporter stated that the patient had lost weight and they felt it was due to this issue.They did not provide 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: 24250808
• Report Number: 1722139-2026-00046
• Device Sequence Number: 13160162
• 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,Followup
• Report Date (Section B): 01/07/2026

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: CF2530411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2026
• Supplement Date Received by Manufacturer: 01/07/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2025
• 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 Age: 4 YR
• Patient Sex: Unknown