MAUDE Adverse Event Report: QUICK SET PARADIGM; UNO QUICK-SET 110/6 PCC MECA

Model Number	MMT-398
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Split, Cut or Torn (4008)
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) 2021, the patient's infusion set's tubing torn off about 18 hours after using the set.The insertion site was patient's right thigh, and this infusion set was the first one from the box.No further information available.
Event or Problem Description
On 18-feb-2022: follow up information was submitted to update the awareness date.Moreover, the result of the (complaint investigation) of returned used (1 tubing), the tubing was returned with damages (cut).Based on the result: medical device problem code, component code, type of investigation code, investigation findings code and investigation conclusions code were updated.Unomedical reference number (b)(4).Event occurred in the united states on (b)(6) 2021, the patient's infusion set's tubing torn off about 18 hours after using the set.The insertion site was patient's right thigh, and this infusion set was the first one from the box.No further information available.

• Brand Name: QUICK SET PARADIGM
• Common Device Name: UNO QUICK-SET 110/6 PCC MECA
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 12834253
• Report Number: 3003442380-2021-00717
• Device Sequence Number: 14612245
• Product Code: FPA
• UDI-Device Identifier: 05705244006690
• UDI-Public: 05705244006690
• 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,Followup
• Report Date (Section B): 02/18/2022

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 Expiration Date: 10/01/2023
• Device Model Number: MMT-398
• Device Lot Number: 5338737
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2021
• Supplement Date Received by Manufacturer: 01/10/2022
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown