MAUDE Adverse Event Report: Moog Medical Devices Enteralite Infinity Enteral Feeding Pump; Enteral Infusion Pump

Model Number	INFKIT2
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/28/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The initial reporter stated that the pump appeared to be running, but was not delivering.They stated they did not know what the pump shows it delivered or the estimated amount that was delivered because "they do not pay attention".They reported using nourish.Mmd did not follow up with the initial reporter because when the complaint was reported they stated there were no adverse effects to the patient and that they had no further information."[complaint- (b)(4)]".
Additional Manufacturer Narrative
The device was not returned to mmd for evaluation.A dhr review 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 mmd.

• Brand Name: Enteralite Infinity Enteral Feeding Pump
• Common Device Name: Enteral Infusion Pump
• 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, cri 20113 ; CS 20113
• Manufacturer Contact: kristin egelhoff ; 4314 zevex park lane; salt lake city, UT 84123 ; +1(801)264-1001
• MDR Report Key: 50858573
• Report Number: 1722139-2026-00255
• Device Sequence Number: 9497846
• Product Code: LZH
• UDI-Device Identifier: 10814844000075
• UDI-Public: 10814844000075
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K031199
• 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): 08/28/2026

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: INFKIT2
• Device Catalogue Number: INFKIT2
• Device Lot Number: N/A
• 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: 08/28/2026
• Initial Report FDA Received Date: 09/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/03/2024
• Is the Device Labeled for Single Use? (Y/N): No
• 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: Unknown