MAUDE Adverse Event Report: MIO; INSET II 80/9 PCC GREY

Model Number	MMT-975600
Medical Device Problem Code	Detachment of Device or Device Component (2907)
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 (b)(6).The patient reported that the infusion set's tubing got detached where the cannula is connected while he was sitting down at his laptop doing work.The site location was patient's abdomen and the pump was clipped on to his belt.Moreover, the infusion had been used for two days.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.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 18-mar-2021: follow up information was submitted for updating health effect - impact code and component code.Also, result of complaint investigation of the returned used device (1 tubing) showed that the tubing was detached from the tubing connector.Based on the result: type of investigation code, investigation findings code and investigation conclusions code were updated.Unomedical reference number (b)(4).Event occurred in canada.The patient reported that the infusion set's tubing got detached where the cannula is connected while he was sitting down at his laptop doing work.The site location was patient's abdomen and the pump was clipped on to his belt.Moreover, the infusion had been used for two days.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.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 80/9 PCC GREY
• MDR Report Key: 10760577
• Report Number: 3003442380-2020-00439
• Device Sequence Number: 11597211
• Product Code: FPA
• UDI-Device Identifier: 05705244007857
• UDI-Public: 05705244007857
• 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: 12/01/2022
• Device Model Number: MMT-975600
• Device Lot Number: 5304729
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2020
• Supplement Date Received by Manufacturer: 10/20/2020
• Initial Report FDA Received Date: 10/30/2020
• Supplement Report FDA Received Date: 03/18/2021
• Patient Sequence Number: 1