MAUDE Adverse Event Report: UNOMEDICAL A/S MEDTRONIC EXTENDED INFUSION SET; UNO EWIS BLUE 60/9 HCAP 3-PK INT

Model Number	MMT-441AH
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: patient city: (b)(6), patient country: united states.H11: since no lot number is available, a detailed investigation, tests on reference samples or batch review cannot be conducted.Therefore, this complaint will be closed, this issue will be monitored through post marketing surveillance (pms) product trends and malfunction.If any trends picked up, this will flag on the trips and alerts according to the on market quality review (omqr) procedure.
Event or Problem Description
Reference number (b)(4).Event occurred in the united states.It was reported that patient faced infusion set leakage event on (b)(6) 2024.The leakage was from the tube.The infusion set was in use just inserted.No further information was available.

• Brand Name: MEDTRONIC EXTENDED INFUSION SET
• Common Device Name: UNO EWIS BLUE 60/9 HCAP 3-PK INT
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 20804123
• Report Number: 8021545-2024-04667
• Device Sequence Number: 9830773
• Product Code: FPA
• UDI-Device Identifier: 05705244023284
• UDI-Public: 05705244023284
• 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): 11/03/2024

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-441AH
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2024
• Initial Report FDA Received Date: 11/28/2024
• 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