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

Model Number	MMT-399600
Medical Device Problem Code	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
(b)(4).Event occurred (b)(6).It was reported that the patient's infusion set's tubing came apart at the tubing connector while sleeping.The site location was left side of the patient's abdomen and the pump was worn in relation to the site.The infusion set had been used for six hours.Moreover, the infusion sets were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.Reportedly, there was stress or pull on the tubing as the patient was sleeping, when this issue occurred.Further, the pump was not dropped with the set connected to the patient's body.No further information available.
Event or Problem Description
On 15-jun-2021: follow up information was submitted to update the awareness date.Moreover, the result of the (complaint investigations) visual inspection and tests for static pull were performed on the returned used device (one set) which showed that the tubing was detached from the tubing-tubing connector.Based on the result: type of investigation code, investigation findings code and investigation conclusions code were updated.Unomedical reference number (b)(4).Event occurred in (b)(6).It was reported that the patient's infusion set's tubing came apart at the tubing connector while sleeping.The site location was left side of the patient's abdomen and the pump was worn in relation to the site.The infusion set had been used for six hours.Moreover, the infusion sets were not stored or used in a place where they might have been exposed to extreme temperatures and humidity.Reportedly, there was stress or pull on the tubing as the patient was sleeping, when this issue occurred.Further, 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: UNO QUICK-SET 60/6 PCC MCAN
• MDR Report Key: 11146420
• Report Number: 3003442380-2021-00110
• Device Sequence Number: 3472115
• 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 Model Number: MMT-399600
• Device Lot Number: UNKNOWN
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/18/2020
• Supplement Date Received by Manufacturer: 06/03/2021
• Initial Report FDA Received Date: 01/11/2021
• Supplement Report FDA Received Date: 06/14/2021
• Patient Sequence Number: 1