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

Model Number	MMT-943600
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).On (b)(6) 2021, the patient reported that she was pregnant and has noticed that nine of the infusion sets she used leaked on the site.The infusion set had been used for one day (few hours).Moreover, there was no stress or pull on the tubing.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 60/6 PCC BLUE MCAN
• MDR Report Key: 11587920
• Report Number: 3003442380-2021-00190
• Device Sequence Number: 2956145
• 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?: Yes
• Is this a Product Problem Report?: No
• 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: 03/09/2021
• Initial Report FDA Received Date: 03/30/2021
• Patient Sequence Number: 1