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

Model Number	MMT-975
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
During quality review process, unomedical has captured this incident and deemed it reportable.Unomedical reference number (b)(4).Event occurred in the united states.On (b)(6) 2019, it was reported that while the patient was sleeping, the infusion set's tubing came apart from where it was connecting.The site location was patient's abdomen and the pump was located on the right side.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: 11751332
• Report Number: 3003442380-2021-00231
• Device Sequence Number: 3778467
• Product Code: FPA
• UDI-Device Identifier: 05705244007833
• UDI-Public: 05705244007833
• 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

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 Model Number: MMT-975
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/30/2019
• Initial Report FDA Received Date: 04/30/2021
• Patient Sequence Number: 1