MAUDE Adverse Event Report: MIO; INSET II 60/6 PCC BLUE

Model Number	MMT-943600
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's mother reported that on (b)(6) 2020, her son's infusion set's tubing detached at the tubing connector while her son went in the pool for swimming.This issue occurred with three infusion sets.The site location was patient's left abdomen and lower back.Moreover, the patient was not disconnected to the pump.The infusion had been in use since (b)(6) 2020.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.The patient's mother was unsure whether there was any 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 60/6 PCC BLUE
• MDR Report Key: 10939511
• Report Number: 3003442380-2020-00463
• Device Sequence Number: 3186840
• Product Code: FPA
• UDI-Device Identifier: 05705244007512
• UDI-Public: 05705244007512
• 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-943600
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 12/03/2020
• Patient Sequence Number: 1