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

Lot Number 5407389

Device Problem Material Twisted/Bent (2981)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in the united states on 27-nov-2023, it was reported that the patient faced a bent cannula due to which her blood glucose level reached 611 mg/dl and she suffered a heart attack, therefore, on 10-dec-2023, she went to the hospital due to high blood glucose level.During hospitalization, she was treated with intravenous injection and stayed there for few days.Unomedical do not see bent/kinking as being related to human factors, but rather as a training issue including correct choices of insertion sites and infusion sets and cannula length.Furthermore, the soft cannula is a flexible material that during use and upon removal can bend slightly.No further information was available.

• Brand Name: QUICK SET PARADIGM
• Type of Device: UNO QUICK-SET 60/6 SC1 MECA
• Manufacturer Contact: osted; lejre
• MDR Report Key: 18450787
• MDR Text Key: 332174756
• Report Number: 3003442380-2024-00108
• 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: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 5407389
• Initial Date Manufacturer Received: 12/28/2023
• Initial Date FDA Received: 01/05/2024
• Patient Sequence Number: 1