MAUDE Adverse Event Report: UNOMEDICAL A/S MEDTRONIC EXTENDED; 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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial and final mdr (b)(4) - device 2 of 2 e1: patient city: (b)(6).Patient country: canada.
Event or Problem Description
Reference number (b)(4).Event occurred in canada.It was reported on 06-jul-2024 two infusion set tape was not sticking and set has been used for 3 days.No further information available.
Additional Manufacturer Narrative
Additional information - this mdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions.H11: investigation summary: "trend observed: increase in complaints related to adhesive on ewis" has been opened on 18-sep-2024 to address all adhesive issues related to ewis product family as no specifications exist for the adhesive used on this product (design related capa).
Event or Problem Description
To date no additional patient or event details have been received.
Additional Manufacturer Narrative
Supplemental report 02 - (b)(4).Additional information - this mdr is being submitted to include the below: h6: investigation results under type of investigation, investigation findings, investigation conclusions.H11: investigation summary.Capa-2010953 "trend observed: increase in complaints related to adhesive on ewis" has been opened on 18-sep-2024 to address all adhesive issues related to ewis product family as no specifications exist for the adhesive used on this product (design related capa).
Event or Problem Description
To date no additional patient or event details have been received.

• Brand Name: MEDTRONIC EXTENDED
• 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: 19935771
• Report Number: 8021545-2024-03123
• Device Sequence Number: 20056204
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/17/2024

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 Expiration Date: 10/01/2025
• Device Model Number: MMT-441AH
• Device Lot Number: 6004184
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Supplement Date Received by Manufacturer: 11/19/2024; 12/17/2024
• Initial Report FDA Received Date: 08/07/2024
• Supplement Report FDA Received Date: 12/17/2024; 01/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• 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