MAUDE Adverse Event Report: MIO; UNO INSET II 46/6 SC1 BLUE MCAN

Lot Number	6000281
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 6 of 6.
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the canada.On 17 apr 2024, it was reported that six out of ten infusion sets have failed to last less than a day due to leakage.Infusion sets have been in use for hours not for a complete day.The sets have been leaking out from the bottom that clips to the pump and the patient states the tubing did not come apart.No further information available.

• Brand Name: MIO
• Common Device Name: UNO INSET II 46/6 SC1 BLUE MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19348403
• Report Number: 3003442380-2024-02536
• Device Sequence Number: 6989425
• Product Code: FPA
• UDI-Device Identifier: 05705244020306
• UDI-Public: 05705244020306
• 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): 05/18/2024

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 Expiration Date: 02/01/2026
• Device Lot Number: 6000281
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Initial Report FDA Received Date: 05/19/2024
• Patient Sequence Number: 1
• Patient Sex: Unknown