MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; QUICK-SET 80/9 PCC

Lot Number 5206436

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

(b)(4).Event occurred in the united states.The patient had a box of quickset paradigm and the cord detached from the ring.I had to replace the cord.The patient faced same issue with 6 infusion sets and it happened while sleeping.Reportedly, the location of detachment was quick release on the insertion end and the infusion was being used for 2 days.Also, 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 80/9 PCC
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 8198429
• MDR Text Key: 131465993
• Report Number: 3003442380-2018-00168
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006577
• UDI-Public: 05705244006577
• 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: 12/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/01/2021
• Device Lot Number: 5206436
• Date Manufacturer Received: 11/28/2018
• Type of Device Usage: N
• Patient Sequence Number: 1