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 Codes	No Known Impact Or Consequence To Patient (2692); 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.The patient's mother reported that the infusion set's tubing detached when the set was just about to be inserted.The site location was the patient's abdomen.The infusions were stored at the home.There was no stress or pull on the tubing and the pump was not dropped with the set connected to their body.No further information available.
Event or Problem Description
On 23-sep-2020: follow up information was submitted to update health effect - impact code and result of complaint investigation of the of the returned used device (1 set) showed that all test results were within specifications.Based on the result: medical device problem 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.The patient's mother reported that the infusion set's tubing detached when the set was just about to be inserted.The site location was the patient's abdomen.The infusions were stored at the home.There was no stress or pull on the tubing and the pump was not dropped with the set connected to their body.No further information available.

• Brand Name: MIO
• Common Device Name: INSET II 60/6 PCC BLUE
• MDR Report Key: 10108691
• Report Number: 3003442380-2020-00282
• Device Sequence Number: 3448424
• 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
• 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: 12/01/2022
• Device Model Number: MMT-943
• Device Lot Number: 5304699
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 05/21/2020
• Initial Report FDA Received Date: 06/02/2020
• Supplement Report FDA Received Date: 09/22/2020
• Patient Sequence Number: 1