MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 80/9 PCC

Lot Number	5262893
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 united states.The patient reported that in the morning of (b)(6) 2019, when she woke up, the line was cut off from the body at the quick release.The site location was her lower left and right stomach.The pump was located on the right side of her bed.The infusion had been in use for one day.Reportedly, the infusions were stored in a box in the closet and a freezer bag in the bedroom.She 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 performed on the returned use 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 80/9 PCC
• MDR Report Key: 9232590
• Report Number: 3003442380-2019-01862
• Device Sequence Number: 343994
• Product Code: FPA
• UDI-Device Identifier: 05705244006577
• UDI-Public: 05705244006577
• 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: 11/01/2021
• Device Lot Number: 5262893
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 10/24/2019
• Patient Sequence Number: 1