MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 46/6 PCC

Lot Number	5233651
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).On (b)(6) 2019, the patient reported that she had two inf sets from the same box that detached from the quick release, one in the morning when she woke up after sleeping and the other when she was at work.The site location was both of her arms once right, last night left and the pump was located on the center of her body.The infusion had been used for two full days and they were stored in the bedroom closet (at room temperature).There was no 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 tubing), it was found that the tubing was detached from the tubing connector.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Common Device Name: QUICK-SET 46/6 PCC
• MDR Report Key: 9382286
• Report Number: 3003442380-2019-01936
• Device Sequence Number: 13570651
• Product Code: FPA
• UDI-Device Identifier: 05705244006195
• UDI-Public: 05705244006195
• 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: 08/01/2021
• Device Lot Number: 5233651
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/17/2019
• Initial Report FDA Received Date: 11/27/2019
• Patient Sequence Number: 1