MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 60/9 PCC

Model Number	MMT-397600
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).It was reported that while the patient was changing the infusion set, the tubing detached at the site.The site location was right side of patient's belly and the pump was at right side.Moreover, the infusion had not been used.The infusions were stored in proper condition.Reportedly, the patient was unsure whether there was any stress or pull on the tubing and the pump was not dropped with the set connected to patient's body no further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Common Device Name: QUICK-SET 60/9 PCC
• MDR Report Key: 9887259
• Report Number: 3003442380-2020-00227
• Device Sequence Number: 948097
• Product Code: FPA
• UDI-Device Identifier: 05705244006393
• UDI-Public: 05705244006393
• 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: 08/01/2022
• Device Model Number: MMT-397600
• Device Lot Number: 5279089
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2020
• Initial Report FDA Received Date: 03/27/2020
• Patient Sequence Number: 1