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

Lot Number	5234901
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 the patient was sleeping, the tubing came out at the quick release.The site location was at the right side of his belly button.The infusion had been in use for two days.Reportedly, the infusions were stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.There was stress or pull on the tubing while the patient was sleeping and the pump was not dropped with the set connected to the patient's body.No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 46/6 PCC BLUE
• MDR Report Key: 8661781
• Report Number: 3003442380-2019-01513
• Device Sequence Number: 244919
• Product Code: FPA
• UDI-Device Identifier: 05705244007314
• UDI-Public: 05705244007314
• 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: 04/01/2021
• Device Lot Number: 5234901
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 06/03/2019
• Patient Sequence Number: 1