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

Model Number	MMT-398
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in the united states.It was reported that the patient's infusion set tubing detached at the quick release.Reportedly, in two out of ten infusion sets, the cap did not lock and one of them came off, the other one did not need to be squeezed to be removed.Moreover, when she puts it on, it seems to be locked in place.The infusion had been used for one day.No further information available.

• Brand Name: QUICK-SET PARADIGM
• Common Device Name: QUICK-SET 110/6 PCC
• MDR Report Key: 10108668
• Report Number: 3003442380-2020-00281
• Device Sequence Number: 11625152
• Product Code: FPA
• UDI-Device Identifier: 05705244006690
• UDI-Public: 05705244006690
• Combination Product (Y/N): N
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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: 09/01/2022
• Device Model Number: MMT-398
• Device Lot Number: 5289898
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 06/02/2020
• Patient Sequence Number: 1