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

Lot Number	5250034
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
(b)(4).Event occurred in (b)(6).The patient reported that infusion set's tubing detached at the site while the patient was sleeping.The site location was patient's leg and the pump was on the belt.The infusion had been in use for two days and the infusions were not stored at extreme temperatures.The patient was unsure of any stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.Upon investigation of the returned used device, it was found that the tubing was detached from the tubing connector.No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 60/6 PCC PINK
• MDR Report Key: 8635066
• Report Number: 3003442380-2019-01491
• Device Sequence Number: 11218067
• Product Code: FPA
• UDI-Device Identifier: 05705244007710
• UDI-Public: 05705244007710
• 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: 08/01/2021
• Device Lot Number: 5250034
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 05/23/2019
• Patient Sequence Number: 1