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

Model Number MMT-941

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event 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 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
• Type of Device: UNO INSET II 46/6 PCC BLUE MIMX
• MDR Report Key: 11241547
• MDR Text Key: 229814348
• Report Number: 3003442380-2021-00119
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244007314
• UDI-Public: 05705244007314
• Combination Product (y/n): Y
• PMA/PMN Number: K160648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/01/2022
• Device Model Number: MMT-941
• Device Lot Number: 5299504
• Date Manufacturer Received: 04/19/2021
• Patient Sequence Number: 1