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 (b)(6).It was reported that while the patient was sleeping, the infusion set's tubing had detached close to the site location.Further, the patient noticed it when she woke up, and it was the second set from the box but the first one worked fine.She had a set change and it was going well.The site location was her left leg and the pump was located on the same side, clipped on the pocket.Moreover, the infusion had been used for two days.Reportedly, the infusions were stored in a box in the bedroom (no extreme temperatures).There was no stress or pull on the tubing and 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 60/6 PCC BLUE
• MDR Report Key: 9961305
• Report Number: 3003442380-2020-00249
• Device Sequence Number: 16329117
• 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: 03/01/2022
• Device Model Number: MMT-943
• Device Lot Number: 5275629
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2020
• Initial Report FDA Received Date: 04/15/2020
• Patient Sequence Number: 1