MAUDE Adverse Event Report: MIO; INSET II 80/9 PCC GREY

Model Number	MMT-975600
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 (b)(6).The patient reported that the infusion set's tubing had separated from the cannula while priming the tubing.Further, the patient had just primed it and was getting ready to insert an infusion set.The infusion had been used for the same day.The infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.Moreover, there was no 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 (one used connector), it was found that the tubing connector detached (missing glue) also a drop of glue on the top of the infusion set connector was found.No further information available.

• Brand Name: MIO
• Common Device Name: INSET II 80/9 PCC GREY
• MDR Report Key: 10418858
• Report Number: 3003442380-2020-00359
• Device Sequence Number: 3066012
• Product Code: FPA
• UDI-Device Identifier: 05705244007857
• UDI-Public: 05705244007857
• 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: 11/01/2021
• Device Model Number: MMT-975600
• Device Lot Number: 5263167
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2020
• Initial Report FDA Received Date: 08/18/2020
• Patient Sequence Number: 1