MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 110/9 PCC

Lot Number	5175942
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 came apart near the set while sleeping at night.The site location was left side of buttock area and the pump was attached to the pajama bottom on the right side.The infusion had been in use for two days and the infusions were stored in a cupboard at regular temperature.Reportedly, the patient was unsure if there was any stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.Upon investigation of the returned used device (1 set), it was found that the tubing was detached from the tubing connector.No further information was available.

• Brand Name: QUICK-SET® PARADIGM®
• Common Device Name: QUICK-SET 110/9 PCC
• MDR Report Key: 8801436
• Report Number: 3003442380-2019-01630
• Device Sequence Number: 13534755
• Product Code: FPA
• UDI-Device Identifier: 05705244006751
• UDI-Public: 05705244006751
• 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: 09/01/2020
• Device Lot Number: 5175942
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 07/18/2019
• Patient Sequence Number: 1