MAUDE Adverse Event Report: UNOMEDICAL A/S MEDTRONIC EXTENDED; UNO EWIS BLUE 80/9 HCAP 3-PK INT

Model Number	MMT-442AH
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient city: (b)(6).Patient country: canada.
Event or Problem Description
Reference number:(b)(4).Event occurred in canada it was reported that the patient faced infusion set block alarm event on unknown date.The blockage was at the site.No further information was 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.Complaint investigation results: a complaint investigation has been initiated.The reference samples for the lot 6003591 have been tested in the trackwise record complaint (b)(4) on 14-may-2025.Test results: the reference samples were visually inspected and functionally leak tested.All test results were within specifications as per the complaint (b)(4) complaint test report.Pdf attached in this record.Device history record (dhr) review: the lot 6003591 was manufactured according to version 79 appendix 1 batch card for production of packaging room, on 26-oct-2023, 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.Trending: a query was run in database on 14-may-2025 against malfunction code occlusion in the tubing and/or tubing connectors (e.G.Occlusion alarm from the infusion pump may have sounded) and lot 6003591 with no other complaints identified.Conclusion summary of complaint investigation: as a result of the following: no defect on tests for reference samples, no non-conformance (nc) raised during production related to complaint code, no trend identified for the lot in question and malfunction code, no further actions are required.This complaint will not require further root cause investigation nor 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
• Common Device Name: UNO EWIS BLUE 80/9 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: 20795726
• Report Number: 8021545-2024-04586
• Device Sequence Number: 7809643
• Product Code: FPA
• UDI-Device Identifier: 05705244023314
• UDI-Public: 05705244023314
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2025

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: 01/10/2023
• Device Model Number: MMT-442AH
• Device Lot Number: 6003591
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/30/2024
• Supplement Date Received by Manufacturer: 05/14/2025
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/10/2022
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown