MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. MIO; UNO INSET II 80/9 SC1 GREY MIMX

Model Number	MMT-975A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/16/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: patient city - (b)(6).Patient country - united arab emirates.
Event or Problem Description
Reference number (b)(4).Event occurred in the united arab emirates.It was reported that the patient experienced an event in which infusion set packaging was not in good condition/ damaged on (b)(6) 2025.No further information available.
Additional Manufacturer Narrative
Additional information - this mdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions.H11: investigation summary.Complaint investigation results: a complaint investigation has been initiated under complaint investigation child record (b)(4).The batch 6003342, in question was manufactured at the reynosa site.Threshold analysis: a query was run on 06/nov/2025 against "final reporting decision equal "serious injury" and "death" , "lot number" criteria equal "6003342".The count of complaint is 2 which is below 3.No further statistical trending analysis is required.Device history record (dhr) review: the lot 6003342 was manufactured according to the work instruction (wi) version 66 and manufactured in the line l10 on 08-feb-2024, with a total of (b)(4) units.Review of the dhr showed that all relevant tests required during the related processes had been fulfilled and met the requirements.No deviation was identified, nor maintenance events were recorded related to complaint code.Test results: no photo was provided.To proceed with product testing, samples from the affected lot were requested.However, the customer has confirmed that no samples are available for investigation.Conclusion summary of complaint investigation: as a result of the following: no physical samples were returned, no non-conformance (nc) raised during production unrelated to complaint code, no trend identified for the lot in question, no further actions are required.This complaint will not require further root cause investigation nor corrective and preventive action (capa) plan.Therefore, this issue will be monitored through the post market surveillance activities.
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: MIO
• Common Device Name: UNO INSET II 80/9 SC1 GREY MIMX
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A. DE C.V.; ave. fomento industrial l9 m3; parque industrial del norte; reynosa, tamaulipas, c.p., 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 22735359
• Report Number: 3003442380-2025-12517
• Device Sequence Number: 17941735
• Product Code: FPA
• UDI-Device Identifier: 05705244020184
• UDI-Public: 05705244020184
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2025

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: Lay User/Patient
• Device Model Number: MMT-975A
• Device Lot Number: 6003342
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 08/07/2025
• Supplement Report FDA Received Date: 11/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/08/2024
• 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
• Patient Sex: Unknown