MAUDE Adverse Event Report: MIO; UNO INSET II 46/6 SC1 PINK MCAN

Lot Number	5309814
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 while the patient was sleeping, the infusion set's tubing detached at the quick release.The site location was patient's left thigh and the pump was clipped to patient's underwear.The infusion had been inserted on saturday.Reportedly, the infusions were stored in the kitchen cupboard.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 the complaint investigation performed on the returned used device (1 set), it was found that the tubing was detached from the tubing connector.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 46/6 SC1 PINK MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 16222533
• Report Number: 3003442380-2023-00131
• Device Sequence Number: 17492793
• Product Code: FPA
• UDI-Device Identifier: 05705244020214
• UDI-Public: 5705244020214
• 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): 01/23/2023

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: 01/01/2023
• Device Lot Number: 5309814
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 01/23/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown