MAUDE Adverse Event Report: MIO; UNO INSET II 80/6 SC1 PINK MIMX

Lot Number	5408467
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device 1 of 3.
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in australia.It was reported that patient faced infusion set leak event on 19-apr-2024.The leak was at side of the attachment to the body.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 80/6 SC1 PINK MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19349354
• Report Number: 3003442380-2024-02559
• Device Sequence Number: 7281239
• Product Code: FPA
• UDI-Device Identifier: 05705244019973
• UDI-Public: 05705244019973
• 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
• Report Date (Section B): 05/20/2024

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
• Device Lot Number: 5408467
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2024
• Initial Report FDA Received Date: 05/20/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown