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

Model Number	MMT-442A
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Reference number (b)(4).Event occurred in the united states.On (b)(6) 2024, it was reported that the patient faced infusion set had leakage at quick release site.The infusion set was in use for 2 to 3 days.No further information available.
Additional Manufacturer Narrative
E1: patient city: (b)(6).Patient country: united states.
Additional Manufacturer Narrative
Correction: this mdr is being submitted to correct the 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.
Event or Problem Description
To date, additional patient or event details were received which have been added in h11.

• Brand Name: MEDTRONIC EXTENDED
• Common Device Name: UNO EWIS BLUE 80/9 HCAP 3-PACK
• 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: 20209305
• Report Number: 8021545-2024-03628
• Device Sequence Number: 8151642
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2025

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: 09/01/2025
• Device Model Number: MMT-442A
• Device Lot Number: 6003300
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 02/13/2025
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2023
• 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