MAUDE Adverse Event Report: QUICK-SET PARADIGM; UNO QUICK-SET 80/6 PCC MCAN

Model Number MMT-387600

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in (b)(6).On 24-dec-2020, the patient reported that the infusion set's tubing detached at the tubing connector.The patient stated that she had a blockage at the tubing connector, and she had to change the entire infusion set.Moreover, the patient had not used the infusion set.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.There was no stress or pull on the tubing and the pump was not dropped with the set connected to patient's body.No further information available.

Event Description

On 08-mar-2021: follow up information was submitted to update the awareness date.Also, a visual inspection and static pull of tubing-tubing connector test were performed on the returned used device (1 set), it was found that all the test results were within specifications.Based on the result: medical device problem code, component code, type of investigation code, investigation findings code and investigation conclusions code were updated.Unomedical reference number (b)(4).Event occurred in canada.On (b)(6) 2020, the patient reported that the infusion set's tubing detached at the tubing connector.The patient stated that she had a blockage at the tubing connector, and she had to change the entire infusion set.Moreover, the patient had not used the infusion set.Reportedly, the infusions were not stored, or used, in a place where they might have been exposed to extreme temperatures and humidity.There was no 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
• Type of Device: UNO QUICK-SET 80/6 PCC MCAN
• MDR Report Key: 11146162
• MDR Text Key: 227093767
• Report Number: 3003442380-2021-00108
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006478
• UDI-Public: 05705244006478
• Combination Product (y/n): Y
• PMA/PMN Number: K160648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/01/2021
• Device Model Number: MMT-387600
• Device Lot Number: 5254081
• Date Manufacturer Received: 02/25/2021
• Patient Sequence Number: 1