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 (b)(6).It was reported that the patient's infusion set's tubing came apart at the reservoir/ site, while the patient was walking/ sitting down.Reportedly, the sites got broken and the tubing popped out of the site end.The site location was the patient's right upper buttock and the pump was on the same side.The infusion had been used for the first day.Moreover, the infusion sets were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.There was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.

• Brand Name: QUICK-SET PARADIGM
• Common Device Name: UNO QUICK-SET 60/9 PCC MCAN
• MDR Report Key: 11460998
• Report Number: 3003442380-2021-00169
• Device Sequence Number: 17299418
• 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

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: No Information
• Device Expiration Date: 05/01/2023
• Device Model Number: MMT-397600
• Device Lot Number: 5321879
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/03/2021
• Initial Report FDA Received Date: 03/11/2021
• Patient Sequence Number: 1