MAUDE Adverse Event Report: MIO; INSET II 46/6 PCC BLUE

Model Number	MMT-941
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 the united states.On 10-aug-2020, it was reported that the patient's infusion set's tubing came out of the site location, overnight while the patient was sleeping.She thinks that she might have rolled over the tubing which might have caused some pulling.The site location was her rear back and the pump was laid on the bed.Moreover, the infusion set had been in use for one day.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.The pump was not dropped with the set connected to patient's body.No further information available.

• Brand Name: MIO
• Common Device Name: INSET II 46/6 PCC BLUE
• MDR Report Key: 10418928
• Report Number: 3003442380-2020-00360
• Device Sequence Number: 3066013
• Product Code: FPA
• UDI-Device Identifier: 05705244007314
• UDI-Public: 05705244007314
• 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: 08/01/2022
• Device Model Number: MMT-941
• Device Lot Number: 5292938
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/11/2020
• Initial Report FDA Received Date: 08/18/2020
• Patient Sequence Number: 1