MAUDE Adverse Event Report: UNOMEDICAL DEVICES S.A. DE C.V. MIO; UNO INSET II 46/6 SC1 BLUE MCAN

Model Number	MMT-941A600
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial and final mdr (b)(4).Device 2 of 6.E1: patient city: (b)(6).Patient country: canada.Please note: this mdr is being submitted under unomedical's ongoing complaint remediation efforts associated with capa #1832980, which includes the retrospective review of complaints and the remediation of complaint records and mdr submissions for 2024-2025.Convatec will continue to track and monitor such complaints according to unomedical's complaint handling and capa procedures.
Event or Problem Description
Reference number (b)(4).Event occurred in canada.It was reported that patient faced infusion set leakage from 6 out of 10 infusion sets on (b)(6) 2024.The leakage was from the bottom that clips to the pump.The infusion set was in use for not a complete day.No further information is avaliable.

• Brand Name: MIO
• Common Device Name: UNO INSET II 46/6 SC1 BLUE MCAN
• Manufacturer (Section D): UNOMEDICAL DEVICES S.A. DE C.V.; ave, fomento industrial l9 m3; parque industrial del norte; reynosa, tamaulipas, c.p., mexico 88736 ; MX 88736
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 22200505
• Report Number: 3003442380-2025-10615
• Device Sequence Number: 12453618
• Product Code: FPA
• UDI-Device Identifier: 05705244020306
• UDI-Public: 05705244020306
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/18/2024

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 Expiration Date: 02/01/2026
• Device Model Number: MMT-941A600
• Device Lot Number: 6000281
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/19/2023
• 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