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

Lot Number	5187541
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).On (b)(6) 2019, the patient reported that the infusion set's tubing had detached from the quick release while sleeping last night.The site of location was her hip.The infusion was used for one day and they were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.She stated that there was stress or pull on the tubing as the pump became wrapped when she moved.Further, the pump was not dropped with the set connected to the patient's body.This issue happened twice.Upon visual inspection, it was found that the tubing was detached from the tubing connector.No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 46/6 PCC PINK
• MDR Report Key: 9001026
• Report Number: 3003442380-2019-01805
• Device Sequence Number: 16808502
• Product Code: FPA
• UDI-Device Identifier: 05705244007390
• UDI-Public: 05705244007390
• 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: 04/01/2020
• Device Lot Number: 5187541
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2018
• Initial Report FDA Received Date: 09/12/2019
• Patient Sequence Number: 1