MAUDE Adverse Event Report: MIO; INSET II 46/6 PCC BLUE

Model Number	MMT-941600
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).It was reported by the patient that when the infusion set was unwound from the serter device, the tubing came completely detached.Upon investigation of the returned used device (1 set), it was found that the glue was missing on the tubing connector (glue was misplaced on the tubing connector).No further information available.

• Brand Name: MIO
• Common Device Name: INSET II 46/6 PCC BLUE
• MDR Report Key: 10625005
• Report Number: 3003442380-2020-00410
• Device Sequence Number: 2554577
• Product Code: FPA
• UDI-Device Identifier: 05705244007338
• UDI-Public: 05705244007338
• 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-941600
• Device Lot Number: 5218577
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2020
• Initial Report FDA Received Date: 10/05/2020
• Patient Sequence Number: 1