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
Unomedical reference number (b)(4).Event occurred in the united states it was reported that while insertion, the infusion set's tubing came apart as the whole sticky piece fell apart.Therefore, the patient could not use it.The site location was patient's abdomen and the pump was located on the table.Moreover, the infusion was not even used for a day.Reportedly, the infusions were stored in the bathroom in room temperature.Reportedly, there was no stress or pull on the tubing.No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 60/6 PCC BLUE
• MDR Report Key: 9864145
• Report Number: 3003442380-2020-00215
• Device Sequence Number: 13593456
• 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: 08/01/2022
• Device Model Number: MMT-943
• Device Lot Number: 5288391
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/16/2020
• Initial Report FDA Received Date: 03/23/2020
• Patient Sequence Number: 1