MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 60/6 PCC

Lot Number	5208243
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's tubing detached again at the quick release.Reportedly, she wore the pump and tubing under her night shirt so there was no way for it to get caught at night.She wore pump on same side as insertion.It had happened at different times of the day and from different boxes.She said there was no stress on the tubing.No further information available3003442380.

• Brand Name: QUICK-SET® PARADIGM®
• Common Device Name: QUICK-SET 60/6 PCC
• MDR Report Key: 8447111
• Report Number: 3003442380-2019-00623
• Device Sequence Number: 344215
• Product Code: FPA
• UDI-Device Identifier: 05705244006317
• UDI-Public: 05705244006317
• 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: 12/01/2020
• Device Lot Number: 5208243
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/19/2018
• Initial Report FDA Received Date: 03/25/2019
• Patient Sequence Number: 1