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	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reference number (b)(4).Event occurred in canada.It was reported that patient faced infusion set detachment event on (b)(6) 2024.The site of detachment was blue clip- connected to reservoir.The site of insertion was abdomen.The infusion set was in use for one day.The patient replaced the infusion set and resumed insulin deliveries successfully.No further information available.
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: canada.H11: since no lot number is available, a detailed investigation, tests on reference samples or batch review cannot be conducted.Therefore, this complaint will be closed, this issue will be monitored through pms product trends and malfunction.If any trends picked up, this will flag on the trips and alerts according to the omqr procedure.
Additional Manufacturer Narrative
Correction: this mdr is being submitted to correct the submitted lot number, expiration date under d4 and manufacturing date under h4.Additional information - this mdr is being submitted to include the below: d9: device available for evaluation has been selected as yes & date returned to mfg was added as well.H6: investigation results under type of investigation, investigation findings, investigation conclusions.H11: investigation summary.Complaint investigation results: a complaint investigation has been initiated under complaint investigation child record (b)(4).The batch 6007204, in question was manufactured at the osted site.Device history record (dhr) review: the lot 6007204 was manufactured according to the work instruction (wi) appendix 1 batchcard for production of packaging room on 17-jan-2024, with a total of (b)(4) units.Review of the dhr showed that all relevant tests required during the related processes had been fulfilled and met the requirements.No deviation was identified, nor maintenance events were recorded related to complaint code.Test results: no testing required according to sop, complaint handling (rev.21).Conclusion summary of complaint investigation: as a result of the following: no non-conformance (nc) raised during production related to complaint code, no further actions are required.This complaint will not require further root cause investigation nor corrective and preventive action (capa) plan.Therefore, this issue will be monitored through the post market surveillance activities.
Event or Problem Description
To date no additional patient or event details have been received.

• 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: 21372367
• Report Number: 8021545-2025-00147
• Device Sequence Number: 8460031
• 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: K173879
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/27/2025

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: 05/01/2026
• Device Model Number: MMT-441AH
• Device Lot Number: 6007204
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 12/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2024
• 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