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	06/30/2024
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 was leaking at the site.The infusion set was in use for three days.No further information available.
Additional Manufacturer Narrative
Initial and final device 1 of 2 e1: patient city: (b)(6) patient country: united states.

• 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: 19901516
• Report Number: 8021545-2024-02952
• Device Sequence Number: 17859821
• 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