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

Model Number	MMT-943600
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
(b)(4).Event occurred in (b)(6).It was reported that the patient's infusion set's tubing had detached, as it was accidentally pulled upon installation and the connection part came off.Upon visual inspection performed on the returned used device (1 set), it was found that the tubing was detached from the tubing connector, missing glue in the connection and was noticed excess of glue on the connector.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 60/6 PCC BLUE MCAN
• MDR Report Key: 11336281
• Report Number: 3003442380-2021-00147
• Device Sequence Number: 3372462
• Product Code: FPA
• UDI-Device Identifier: 05705244007512
• UDI-Public: 05705244007512
• 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 Model Number: MMT-943600
• Device Lot Number: 5296202
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 02/17/2021
• Patient Sequence Number: 1