MAUDE Adverse Event Report: MIO; UNO INSET II 46/6 PCC BLUE MIMX

Model Number	MMT-941
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 Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2021, it was reported by the patient's parent that their son's infusion set's tubing was pulled out on the needle and tape part.Reportedly, it seemed like the tubing was not properly glued on the site part.No further information available.
Event or Problem Description
On 26-apr-2021: follow up information was submitted to update the awareness date.Moreover, the result of the (complaint investigations) visual inspection and tests for click and static pull on tubing connector were performed on the returned used device (one set) which showed that all test results were within specifications.Based on the result: medical device problem code, component code, type of investigation code, investigation findings code and investigation conclusions code were updated.Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2021, it was reported by the patient's parent that their son's infusion set's tubing was pulled out on the needle and tape part.Reportedly, it seemed like the tubing was not properly glued on the site part.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 46/6 PCC BLUE MIMX
• MDR Report Key: 11241547
• Report Number: 3003442380-2021-00119
• Device Sequence Number: 3556386
• Product Code: FPA
• UDI-Device Identifier: 05705244007314
• UDI-Public: 05705244007314
• Combination Product (Y/N): Y
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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: 09/01/2022
• Device Model Number: MMT-941
• Device Lot Number: 5299504
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 04/19/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 04/26/2021
• Patient Sequence Number: 1