MAUDE Adverse Event Report: UNOMEDICAL A/S MEDTRONIC EXTENDED INFUSION SET; UNO EWIS BLUE 60/9 HCAP 3-PK INT

Model Number	MMT-441AH
Medical Device Problem Code	Loss of or Failure to Bond (1068)
Health Effect - Clinical Code	Hyperglycemia (1905)
Date of Event	07/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial and final mdr 1932718 - mdr 8021545-2024-03010 - device 2 of 3.E1: patient city: (b)(6).Patient country: canada.
Event or Problem Description
Reference number (b)(4).Event occurred in canada.It was reported that patient faced an 3 infusion sets leakage event at the site.The infusion set was in use for 4 days.No further information was available.

• Brand Name: MEDTRONIC EXTENDED INFUSION SET
• Common Device Name: UNO EWIS BLUE 60/9 HCAP 3-PK INT
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre, 4320 ; DA 4320
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19916814
• Report Number: 8021545-2024-03010
• Device Sequence Number: 8337120
• Product Code: FPA
• UDI-Device Identifier: 05705244023284
• UDI-Public: 05705244023284
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K210544
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/07/2024

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
• Operator of Device: Lay User/Patient
• Device Model Number: MMT-441AH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2024
• Initial Report FDA Received Date: 08/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown