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
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.
Additional Manufacturer Narrative
Initial and final mdr (b)(4) - device 5 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.

• 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: 22200509
• Report Number: 3003442380-2025-10618
• Device Sequence Number: 17833823
• 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