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

Lot Number 5233477

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 (b)(6).The patient reported infusion set was broken/bent between insertion side/connector and tubing connector.The location of detachment was between insertion side/connector and tubing connector.The pump was in right side of the pocket.The infusion had been in use for 2 days.The patient reported 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 80/6 PCC
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 8193686
• MDR Text Key: 131339681
• Report Number: 3003442380-2018-00159
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006492
• UDI-Public: 05705244006492
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 05/01/2021
• Device Lot Number: 5233477
• Initial Date Manufacturer Received: 11/23/2018
• Initial Date FDA Received: 12/24/2018
• Type of Device Usage: N
• Patient Sequence Number: 1