MAUDE Adverse Event Report: MIO¿; INSET II 60/6 PCC PINK

Lot Number	5244156
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.The patient reported that on (b)(6) 2018, when she woke up in the morning, her infusion set's tubing detached from the tubing connector, while sleeping.This issue occurred twice.The site location was at the patient's right hip and the pump was laid on the bed.The infusion had been in use for a day.Reportedly, the infusions were stored on the dresser, in patient's room.There was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.Upon investigation performed on the returned used device (3 tubing's), it was found that the tubing's were detached from the tubing connectors.No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 60/6 PCC PINK
• MDR Report Key: 9254149
• Report Number: 3003442380-2019-01895
• Device Sequence Number: 16614206
• Product Code: FPA
• UDI-Device Identifier: 05705244007697
• UDI-Public: 05705244007697
• 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: 07/01/2021
• Device Lot Number: 5244156
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/30/2018
• Initial Report FDA Received Date: 10/30/2019
• Patient Sequence Number: 1