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	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial and final mdr 1931136 - mdr 8021545-2024-02954- device 1 of 2.E1: patient city: (b)(6).Patient country: united states.
Event or Problem Description
Reference number (b)(4).Event occurred in the united states.On 27-jun-2024, it was reported that the patient faced infusion set was leaking at the site.The infusion set was in use for three days.No further information available.

• 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: 19901518
• Report Number: 8021545-2024-02954
• Device Sequence Number: 20550282
• 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): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/05/2024

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 Model Number: MMT-442AH
• Device Lot Number: 6005411
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 08/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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