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

Model Number	MMT-398600
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).On (b)(6) 2021, it was reported that the infusion set's tubing detached at the quick release while the patient was sleeping.The site location was right side of patient's abdomen and the pump was located on the bed.Moreover, the infusion had been used for two days.Reportedly, the infusions were stored in the kitchen pantry.The patient was unsure whether there was stress of pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information available.

• Brand Name: QUICK-SET PARADIGM
• Common Device Name: UNO QUICK-SET 110/6 PCC MCAN
• MDR Report Key: 11347393
• Report Number: 3003442380-2021-00154
• Device Sequence Number: 3416106
• Product Code: FPA
• UDI-Device Identifier: 05705244006676
• UDI-Public: 05705244006676
• 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: 11/01/2021
• Device Model Number: MMT-398600
• Device Lot Number: 5260565
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2021
• Initial Report FDA Received Date: 02/19/2021
• Patient Sequence Number: 1