MAUDE Adverse Event Report: MIO; UNO INSET II 60/6 SC1 BLUE MCAN

Model Number	MMT-943A600
Medical Device Problem Code	Detachment of Device or Device Component (2907)
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 canada.On (b)(6) 2022, it was reported that the patient's infusion set's tubing detached from the quick release while the patient was sleeping.The site location was patient's abdomen.Moreover, the infusion had been used for one day.Reportedly, the infusions were stored normally.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.According to complaint investigation performed on the returned used device (1 tubing), the tubing was detached from the tubing connector as it was not properly assembled.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 60/6 SC1 BLUE MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 17017099
• Report Number: 3003442380-2023-00268
• Device Sequence Number: 20374363
• Product Code: FPA
• UDI-Device Identifier: 05705244020337
• UDI-Public: 05705244020337
• 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): 05/29/2023

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: 11/01/2024
• Device Model Number: MMT-943A600
• Device Lot Number: 5371959
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 05/29/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown