MAUDE Adverse Event Report: ASEPT PAK NUTRIFILL

Lot Number	HFH OR HKK
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Codes	Red Eye(s) (2038); Eye Infections (4466); Eye Pain (4467)
Date of Event	12/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Patient (b)(6) indicated that they had experienced eye pain and burning/stinging in right eye, especially when blinking.The pain subsided whilst wearing lenses during the day but later got worse.(b)(6) indicated that they visited their doctor the following day and was diagnosed with a corneal ulcer.

• Brand Name: NUTRIFILL
• Common Device Name: NUTRIFILL
• Manufacturer (Section D): ASEPT PAK; 64 west st; malone NY 12953
• Manufacturer (Section G): ASEPT PAK; 64 west st; malone NY 12953
• Manufacturer Contact: jessica labriola ; 806 kimball ave; grand junction, CO 81501 ; 9709854240
• MDR Report Key: 22318874
• Report Number: 3016114779-2025-00041
• Device Sequence Number: 8948575
• Product Code: MRC
• UDI-Device Identifier: 00850012123002
• UDI-Public: 00850012123002
• Combination Product (Y/N): N
• Initial Reporter State: CO
• Initial Reporter Country: US
• PMA/510(K) Number: K181566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 06/24/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2026
• Device Lot Number: HFH OR HKK
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2025
• Initial Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female