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

Model Number	MMT-943
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
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.On (b)(6) 2020, the patient reported that the infusion set's tubing detached at the quick release while the patient was in process of changing.Therefore, the introducer needle was hard to remove.The site location was patient's abdomen and the pump was located in her bra.Reportedly, the infusions were stored in the cabinet.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.
Event or Problem Description
On 27-aug-2020: follow up information was submitted to update lot number, expiration date and result of complaint investigation of the returned used devices (3 sets) showed that all test results were within specifications.Based on the result: device, method, result and conclusion codes were updated.Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2020, the patient reported that the infusion set's tubing detached at the quick release while the patient was in process of changing.Therefore, the introducer needle was hard to remove.The site location was patient's abdomen and the pump was located in her bra.Reportedly, the infusions were stored in the cabinet.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 60/6 PCC BLUE
• MDR Report Key: 10023879
• Report Number: 3003442380-2020-00258
• Device Sequence Number: 16923404
• Product Code: FPA
• UDI-Device Identifier: 05705244007499
• UDI-Public: 05705244007499
• 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,Followup

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: 12/01/2022
• Device Model Number: MMT-943
• Device Lot Number: 5301136
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2020
• Supplement Date Received by Manufacturer: 04/22/2020
• Initial Report FDA Received Date: 05/05/2020
• Supplement Report FDA Received Date: 08/27/2020
• Patient Sequence Number: 1