MAUDE Adverse Event Report: QUICK SET PARADIGM; UNO QUICK-SET 110/9 SC1 MECA

Lot Number 5407781

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 germany on 20-feb-2024, it was reported that patient's infusion set was detached between the tubing and cannula ring at the tubing connector while sleeping.The site location was patient's abdomen.Moreover, the infusion had been used as per instruction for use.Reportedly, there was no stress or pull on the tubing and the pump was dropped with the set connected to patient's body.No further information available.

• Brand Name: QUICK SET PARADIGM
• Type of Device: UNO QUICK-SET 110/9 SC1 MECA
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18785567
• MDR Text Key: 337423504
• Report Number: 3003442380-2024-00161
• Device Sequence Number: 1
• Product Code: FPA
• 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: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 5407781
• Date Manufacturer Received: 02/21/2024
• Patient Sequence Number: 1