MAUDE Adverse Event Report: CONTAMAC SOLUTIONS, INC NUTRIFILL; PRESERVATIVE FREE BUFFERED SALINE SOLUTION

Model Number	Nutrifill
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Corneal Ulcer (1796); Eye Infections (4466)
Date of Event	07/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Cl called on (b)(6) 2021 to report an adverse event on behalf of tl.Cl said that tl had been fit with a scleral lens in one eye and received samples of the scleral lens filling solution (nutrifill) on (b)(6) and purchased 3 cartons on (b)(6) (delivered (b)(6)).Tl had since been treated for a corneal ulcer, fungal, and parasite infection and saw a corneal specialists (b)(6) for treatment of a corneal ulcer.They had become aware of the recall of the lot foe on the november 1st (5th notice) and called after noting that a corneal ulcer resulting from a cornal abrasion was a potential risk to health.Cl noted that they had not read previous notices (first notice was (b)(6)).When asked when tl discontinued using the solution cl guessed the beginning of july.When asked how the solution was being used cl was unsure, when asked if they still had any product left cl said yes, and counted 2 full cartons and one with 34 ampoules (one missing).Cl was asked to send the remaining product back to be examined and was sent a return package and label.Cl was also asked if we could speak with tl's doctor(s) about what happened and if she had contacted any of them regarding the product.Cl said that was their next step and was asked to please give each doctor our contact information and give them permission to discuss tl's medical records so we could investigate.Cl agreed and provided the names of the practitioners.The return package/label was delivered to tl on (b)(6) and was never used.A message was left for cl on (b)(6).On november 17th a second number on the account was called with no answer.Both numbers were called on december 9th with no answer or voicemail pick-up.No doctor contacted the office.We were unable to verify with a healthcare provider the diagnosis or events or test any samples and were therefore unable to establish a relationship between the product and events and the investigation was closed.On 2/11/2022 the office received a notice that an adverse event had been reported.The investigation was reopened and numbers for tl and cl were called and a message was left on cl voicemail on 2/25/2022 requesting more information and permission to speak about the event with their doctors.Dr.(b)(6) (mentioned as the primary od by cl) was also called and a message was left on 2/28/2022.Dr.(b)(6) office returned the message on 3/1/2022 and said they did not have permission to speak about tl.On 3/8/2022 cl called and said they would not speak to us or provide any additional information.
Additional Manufacturer Narrative
Contamac became aware of an issue in lot foe and immediately suspended sale and notified affected customers on june 28th to discontinue use while the issue was investigated.Small black particles were found in a total of 17 ampoules during visual inspection at the contamac solutions facility prior to order fulfillment.Our manufacturer was notified and we sent the ampoules for testing and investigation.The ampoules with particles were determined to be sterile, and the investigation found the particles to be carbon-based particles that resulted from a step in the manufacturing process where needles are "torched" and purged to clear a resin plugged needle.When assessing the risk to the end user it was determined that the particles could cause mild irritation (minor), a corneal abrasion (significant), and an abrasion renders the patient vulnerable to a corneal ulcer (serious).A voluntary recall was issued out of an abundance of caution and no other adverse events or complaints were reported.While attempting to investigate the complaint from tl, we were unable to evaluate the remaining ampoules from the purchased product, verify the diagnosis, or gain additional details from a healthcare practitioner to understand the relationship between the corneal ulcer and the other conditions (infections).

• Brand Name: NUTRIFILL
• Common Device Name: PRESERVATIVE FREE BUFFERED SALINE SOLUTION
• Manufacturer (Section D): CONTAMAC SOLUTIONS, INC; 806 kimball ave; grand junction CO 81501
• Manufacturer (Section G): ASEPT PAK; 64 west street; malone NY 12953
• Manufacturer Contact: jessica labriola ; 806 kimball ave; grand junction, CO 81501 ; 9709854240
• MDR Report Key: 13944449
• Report Number: 3003936323-2022-00008
• Device Sequence Number: 19925377
• Product Code: MRC
• UDI-Device Identifier: 00850012123002
• UDI-Public: 00850012123002
• Combination Product (Y/N): N
• 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: Consumer,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/16/2022

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: 09/30/2022
• Device Model Number: Nutrifill
• Device Lot Number: FOE
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 03/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2021
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CONTACT LENS CLEANING SOLUTION; SCLERAL CONTACT LENS
• Outcome Attributed to Adverse Event: Required Intervention; Disability
• Patient Age: 55 YR
• Patient Sex: Male