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

Lot Number UNKNOWN

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).It was reported that the ring and the tube disconnected, which the patient noticed immediately and replaced the set.Upon investigation of the returned used tubing, it was found that the tubing was detached from the tubing connector.No further information available.

• Brand Name: QUICK-SET® PARADIGM®
• Type of Device: QUICK-SET 60/6 PCC
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 9514399
• MDR Text Key: 183105154
• Report Number: 3003442380-2019-01986
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244006331
• UDI-Public: 05705244006331
• 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 Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 10/01/2019
• Initial Date FDA Received: 12/24/2019
• Type of Device Usage: N
• Patient Sequence Number: 1