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

Lot Number 5203336

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states.The patient reported, the infusion set tubing came out of the release site and detachment occurred at the quick connector.The patient stated, that the adhesive came off on one and the other couple, the tubing detached on several occasions and the patient had lost several reservoirs because of multiple infusion set issues.Reportedly, the set came out of her body when the patient was sleeping and sitting.The location was upper part of leg and the pump was worn on the hip area (left and right).There was no stress or pull on the tubing and the pump wasn't dropped with the set connected to the body.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Type of Device: QUICK-SET 60/9 PCC
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 8202012
• MDR Text Key: 131586810
• Report Number: 3003442380-2018-00162
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006416
• UDI-Public: 05705244006416
• Combination Product (y/n): N
• PMA/PMN Number: K160648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/01/2020
• Device Lot Number: 5203336
• Date Manufacturer Received: 11/08/2018
• Type of Device Usage: N
• Patient Sequence Number: 1