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

Model Number	MMT-925
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 (b)(6) 2020, the parent of the patient reported that as their daughter woke up this morning, it was noticed that the infusion set's tubing was disconnected from the clip at the quick release, while she was sleeping.Reportedly, the tubing was still connected to the pump and the end looked like a big ball of glue.The site location was her stomach and the pump was probably in pants or shorts.The infusion set was used for a day and they were stored in a plastic shelf container.They were unsure of any stress or pull on the tubing, but the pump was not dropped with the set connected to her body.No further information available.

• Brand Name: MIO
• Common Device Name: INSET II 80/6 PCC PINK
• MDR Report Key: 10447234
• Report Number: 3003442380-2020-00365
• Device Sequence Number: 11833236
• Product Code: FPA
• UDI-Device Identifier: 05705244007871
• UDI-Public: 05705244007871
• 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: 02/01/2023
• Device Model Number: MMT-925
• Device Lot Number: 5311063
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 08/25/2020
• Patient Sequence Number: 1