MAUDE Adverse Event Report: QUICK SET PARADIGM; UNO QUICK-SET 60/9 PCC MCAN

Model Number	MMT-397600
Medical Device Problem Code	Detachment of Device or Device Component (2907)
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 canada on (b)(6) 2022, it was reported that the two infusion sets detached.Further, there was no stress or pull on the tubing.Reportedly, the pump was not dropped with the set connected to their body.No further information available.

• Brand Name: QUICK SET PARADIGM
• Common Device Name: UNO QUICK-SET 60/9 PCC MCAN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 14742014
• Report Number: 3003442380-2022-00772
• Device Sequence Number: 17815642
• Product Code: FPA
• UDI-Device Identifier: 05705244006393
• UDI-Public: 05705244006393
• Combination Product (Y/N): Y
• PMA/510(K) Number: K160648
• 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): 06/20/2022

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 Model Number: MMT-397600
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 06/20/2022
• Patient Sequence Number: 1
• Patient Sex: Unknown