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

Model Number	MMT-943600
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
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 (b)(6).It was reported that the patient's infusion set's tubing detached close to the site location when he suspended the pump, and went to have his shower, reattached and was laying on his bed.The site location was patient's upper left hip and the pump was located on the same side in relation to the site.Moreover, the infusion had been in use 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.The patient 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.
Event or Problem Description
On 06-nov-2020: follow up information was submitted for updating health effect - clinical code and result of complaint investigation of the returned used device (1 tubing) showed that the tubing was damaged (cut).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 canada.It was reported that the patient's infusion set's tubing detached close to the site location when he suspended the pump, and went to have his shower, reattached and was laying on his bed.The site location was patient's upper left hip and the pump was located on the same side in relation to the site.Moreover, the infusion had been in use 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.The patient 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: 9725582
• Report Number: 3003442380-2020-00173
• Device Sequence Number: 16635307
• Product Code: FPA
• UDI-Device Identifier: 05705244007512
• UDI-Public: 05705244007512
• 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 Model Number: MMT-943600
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2020
• Supplement Date Received by Manufacturer: 02/06/2020
• Initial Report FDA Received Date: 02/19/2020
• Supplement Report FDA Received Date: 11/06/2020
• Patient Sequence Number: 1