MAUDE Adverse Event Report: QUICK SET PARADIGM; UNO QUICK-SET 60/6 SC1 MECA

Lot Number 5413182

Device Problem Detachment of Device or Device Component (2907)

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

Event Type  malfunction  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states on 09-apr-2024, it was reported that the patient's infusion set's tube came off from the seal part.No further information available.

• Brand Name: QUICK SET PARADIGM
• Type of Device: UNO QUICK-SET 60/6 SC1 MECA
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 19198817
• MDR Text Key: 342000180
• Report Number: 3003442380-2024-00243
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244017450
• UDI-Public: 05705244017450
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 5413182
• Date Manufacturer Received: 04/10/2024
• Patient Sequence Number: 1