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

Model Number	MMT-965
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 about a damaged infusion set from the package.As the patient opened the shell of the infusion set, while unfurling, the tubing hung up and tangled.The patient noticed that the end of the tubing that should have been connected to the quick release, was loosened and got detached.Moreover, the patient had not used the infusion set and the event occurred prior to use.Reportedly, there was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information available.

• Brand Name: MIO¿
• Common Device Name: INSET II 80/6 PCC GREY
• MDR Report Key: 9630799
• Report Number: 3003442380-2020-00135
• Device Sequence Number: 2800389
• 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: 05/01/2022
• Device Model Number: MMT-965
• Device Lot Number: 5283675
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 01/27/2020
• Patient Sequence Number: 1