MAUDE Adverse Event Report: QUICK SET; UNO QUICK-SET 60/9 MGBW

Model Number	MMT-392
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
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 the united states.On (b)(6) 2023, the patient's mother reported that, a few days ago, there was a small crack and subsequent leakage in one of the needles of the infusion set.No further information available.

• Brand Name: QUICK SET
• Common Device Name: UNO QUICK-SET 60/9 MGBW
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 17314584
• Report Number: 3003442380-2023-00301
• Device Sequence Number: 11771419
• Product Code: FPA
• UDI-Device Identifier: 05705244006294
• UDI-Public: 05705244006294
• Combination Product (Y/N): Y
• PMA/510(K) Number: K991759
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/13/2023

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
• Device Expiration Date: 09/01/2025
• Device Model Number: MMT-392
• Device Lot Number: 5404440
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 07/13/2023
• Patient Sequence Number: 1
• Patient Sex: Unknown