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

Model Number	MMT-943
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
(b)(4).Event occurred in the united states.On (b)(6) 2020, it was reported that the patient woke up with tube broken off at the tubing connector while sleeping.The site location was on the back of her hip and the pump was on the same side.The infusion had been used for two days.The infusions were stored, or used, in a place inside, where they were not exposed to extreme temperatures and humidity.Reportedly, there was no stress or pull on the tubing and the pump was not dropped with the set connected to their body.No further information available.

• Brand Name: MIO
• Common Device Name: INSET II 60/6 PCC BLUE
• MDR Report Key: 10156632
• Report Number: 3003442380-2020-00299
• Device Sequence Number: 3852116
• Product Code: FPA
• UDI-Device Identifier: 05705244007499
• UDI-Public: 05705244007499
• 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: 07/01/2022
• Device Model Number: MMT-943
• Device Lot Number: 5287808
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2020
• Initial Report FDA Received Date: 06/16/2020
• Patient Sequence Number: 1