MAUDE Adverse Event Report: QUICK-SET PARADIGM; QUICK-SET 60/6 PCC

Model Number	MMT-399600
Medical Device Problem Codes	Connection Problem (2900); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).It was reported by the patient that the infusion set's tubing had detached at the quick release while sleeping.The patient had six infusion sets that detached after one day or two.The site location was on the patient's side and the pump was located in the front of the infusion sets.The infusion set had been used for one day and the infusions were stored in the bedroom.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 28-jan-2021: follow up information was submitted for updating health effect impact code and result of the complaint investigation of returned used and unused devices (1 used set, 3 unused sets and 1 used cannula).In the used set (one), it was found that the connection between tubing connector and cannula does not make the click, due to the click-legs of tubing connector have damages (deformed).The static pull test results were found within specifications.Based on the result: component code, type of investigation code, investigation findings code and investigation conclusions code were updated.Unomedical reference number (b)(4).Event occurred in canada.It was reported by the patient that the infusion set's tubing had detached at the quick release while sleeping.The patient had six infusion sets that detached after one day or two.The site location was on the patient's side and the pump was located in the front of the infusion sets.The infusion set had been used for one day and the infusions were stored in the bedroom.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 60/6 PCC
• MDR Report Key: 10598340
• Report Number: 3003442380-2020-00404
• Device Sequence Number: 19689316
• Product Code: FPA
• UDI-Device Identifier: 05705244006317
• UDI-Public: 05705244006317
• Combination Product (Y/N): Y
• PMA/510(K) Number: K160648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• 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: 05/01/2022
• Device Model Number: MMT-399600
• Device Lot Number: 5279072
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 09/17/2020
• Initial Report FDA Received Date: 09/29/2020
• Supplement Report FDA Received Date: 01/28/2021
• Patient Sequence Number: 1