MAUDE Adverse Event Report: QUICK-SET PARADIGM; QUICK-SET 110/6 PCC

Model Number	MMT-398
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 the united states.In the morning of (b)(6) 2019, the patient reported that last night at 3:00 am, the infusion set's tubing became disconnected from the body at the tubing porting while sleeping.Reportedly, the site location was the patient's arm and the pump was on the bra or the shirt.The infusion had been used since yesterday ((b)(6) 2019).Moreover, the infusions were stored in the kitchen.There was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.No further information available.
Event or Problem Description
On 11-mar-2020: follow up information was submitted because result of complaint investigation of the returned used devices (1 tubing and 1 cannula) showed that the tubing was detached from the tubing connector.Based on the result: method, result and conclusion codes were updated.Unomedical reference number (b)(4).Event occurred in (b)(6).In the morning of (b)(6) 2019, the patient reported that last night at 3:00 am, the infusion set's tubing became disconnected from the body at the tubing porting while sleeping.Reportedly, the site location was the patient's arm and the pump was on the bra or the shirt.The infusion had been used since yesterday ((b)(6) 2019).Moreover, the infusions were stored in the kitchen.There was no stress or pull on the tubing and the pump was not dropped with the set connected to the patient's body.No further information available.

• Brand Name: QUICK-SET PARADIGM
• Common Device Name: QUICK-SET 110/6 PCC
• MDR Report Key: 9449088
• Report Number: 3003442380-2019-01965
• Device Sequence Number: 1833915
• Product Code: FPA
• UDI-Device Identifier: 05705244006690
• UDI-Public: 05705244006690
• 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,Followup

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: 12/01/2021
• Device Model Number: MMT-398
• Device Lot Number: 5265821
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 11/20/2019
• Initial Report FDA Received Date: 12/11/2019
• Supplement Report FDA Received Date: 03/11/2020
• Patient Sequence Number: 1