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 the united states on (b)(6) 2021, the patient reported that infusion set's tubing disconnected from the quick release while the set was changed.Further, there was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.Upon visual inspection, of the returned used device (1 set) it was found that the glue in the tubing connector was missing.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 80/9 PCC GREY MIMX
• MDR Report Key: 12230902
• Report Number: 3003442380-2021-00337
• Device Sequence Number: 19730612
• 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: 5311086
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 07/27/2021
• Patient Sequence Number: 1