MAUDE Adverse Event Report: UNOMEDICAL A/S MEDTRONIC EXTENDED; UNO EWIS BLUE 60/6 HCAP 3-PK INT

Model Number	MMT-431AH
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reference number (b)(4).Event occurred in canada.It was reported that patient faced an event where tubing broke in 2 at 3 inches from reservoir on (b)(6) 2024.No further information available.
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: canada.Please note: this mdr is being submitted under unomedical's ongoing complaint remediation efforts associated with capa #1832980, which includes the retrospective review of complaints and the remediation of complaint records and mdr submissions for 2024-2025.Convatec will continue to track and monitor such complaints according to unomedical's complaint handling and capa procedures.

• Brand Name: MEDTRONIC EXTENDED
• Common Device Name: UNO EWIS BLUE 60/6 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, mexico 4320
• MDR Report Key: 22204541
• Report Number: 8021545-2025-01513
• Device Sequence Number: 15384318
• Product Code: FPA
• UDI-Device Identifier: 05705244023161
• UDI-Public: 05705244023161
• 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): 02/14/2024

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: 01/01/2025
• Device Model Number: MMT-431AH
• Device Lot Number: 5413271
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2024
• Initial Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/01/2023
• 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: Female