MAUDE Adverse Event Report: MIO¿; INSET II 80/6 PCC GREY

Lot Number	5143416
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 the infusion set was not attached to the needle portion and was detached at the site portion.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, it was found that there was missing glue in the tubing connector.No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 80/6 PCC GREY
• MDR Report Key: 8468001
• Report Number: 3003442380-2019-00732
• Device Sequence Number: 13933263
• Product Code: FPA
• UDI-Device Identifier: 05705244007796
• UDI-Public: 05705244007796
• 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: 03/15/2019
• Device Lot Number: 5143416
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2017
• Initial Report FDA Received Date: 03/31/2019
• Patient Sequence Number: 1