MAUDE Adverse Event Report: MIO; INSET II 80/6 PCC BLUE

Model Number	MMT-945
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number: (b)(4).Event occurred in united states.The patient reported that she had an infusion set that got detached while she was sleeping, and it has now become lose.Reportedly, the infusion set's tubing got detached at the quick release.The site location was on her right side of abdomen and the pump was located on the belt on the right side.The infusion had been used for two days.Moreover, they were unsure whether there was any stress or pull on the tubing and the pump was not dropped with the set connected to their body.Upon investigation of the returned used device (1 set), it was found that the tubing detached from the tubing connector.No further information available.

• Brand Name: MIO
• Common Device Name: INSET II 80/6 PCC BLUE
• MDR Report Key: 10492737
• Report Number: 3003442380-2020-00373
• Device Sequence Number: 16878781
• Product Code: FPA
• UDI-Device Identifier: 05705244007734
• UDI-Public: 05705244007734
• Combination Product (Y/N): N
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 01/01/2023
• Device Model Number: MMT-945
• Device Lot Number: 5308832
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 09/04/2020
• Patient Sequence Number: 1