MAUDE Adverse Event Report: UNOMEDICAL A/S NERIA MULTI; UNO NERIA MULTI 60+30/10-3 (10/120) GLOB

Model Number	721060-2731
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in germany.It was reported that patient faced infusion set leak where the tube and the patch connect.No further information available.
Additional Manufacturer Narrative
Patient country: germany.

• Brand Name: NERIA MULTI
• Common Device Name: UNO NERIA MULTI 60+30/10-3 (10/120) GLOB
• Manufacturer (Section D): UNOMEDICAL A/S; aaholmvej 1-3; osted; lejre
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19759535
• Report Number: 3003442380-2024-14828
• Device Sequence Number: 8875168
• Product Code: FPA
• UDI-Device Identifier: 05705244002098
• UDI-Public: 05705244002098
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K120395
• 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): 07/17/2024

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: 721060-2731
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2024
• Initial Report FDA Received Date: 07/17/2024
• 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