MAUDE Adverse Event Report: MIO; UNO INSET II 80/9 PCC GREY MIMX

Model Number	MMT-975
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 (b)(6).It was reported that the patient's infusion set's tubing had detached close to site location.The site location was patient's upper thigh and the pump was on the hip area.The infusion has been used for one day.Reportedly, the infusions were stored in a carry case.There was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 80/9 PCC GREY MIMX
• MDR Report Key: 11548440
• Report Number: 3003442380-2021-00182
• Device Sequence Number: 11719972
• Product Code: FPA
• UDI-Device Identifier: 05705244007833
• UDI-Public: 05705244007833
• 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

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: No Information
• Device Expiration Date: 02/01/2023
• Device Model Number: MMT-975
• Device Lot Number: 5308867
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2021
• Initial Report FDA Received Date: 03/23/2021
• Patient Sequence Number: 1