MAUDE Adverse Event Report: MIO; UNO INSET II 80/9 SC1 GREY MCAN

Model Number	MMT-975A600
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).On (b)(6) 2022, the patient's mother reported that her son's infusion set leaked at the site after using it for one day and this issue occurred with ten infusion sets from two boxes.Reportedly, there was no stress or pull on the infusion set tubing.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 80/9 SC1 GREY MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 13657557
• Report Number: 3003442380-2022-00375
• Device Sequence Number: 16620957
• Product Code: FPA
• UDI-Device Identifier: 05705244020429
• UDI-Public: 05705244020429
• Combination Product (Y/N): Y
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/03/2022

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
• Device Expiration Date: 03/01/2023
• Device Model Number: MMT-975A600
• Device Lot Number: 5313465
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/20/2022
• Initial Report FDA Received Date: 03/03/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown