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

Lot Number	5138481
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 (b)(6).The patient reported that the infusion set tubing's came apart at quick release while sleeping.The site was at the leg and the pump was located on the belt loop.The infusion was in use for one day.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.The patient was uncertain whether there was stress or pull on the tubing as he was sleeping when he woke up the tubing was dangling and the pump was not dropped with the set connected to the patient's body.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Common Device Name: QUICK-SET 110/6 PCC
• MDR Report Key: 8467989
• Report Number: 3003442380-2019-00831
• Device Sequence Number: 1501314
• Product Code: FPA
• UDI-Device Identifier: 05705244006676
• UDI-Public: 05705244006676
• 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: 06/15/2019
• Device Lot Number: 5138481
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2017
• Initial Report FDA Received Date: 03/31/2019
• Patient Sequence Number: 1