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

Lot Number 5394045

Device Problem Material Twisted/Bent (2981)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in saudi arabia.On (b)(6) 2024, it was reported that the patient faced a bent cannula due to which the patient experienced high blood glucose level, vomiting and abdominal pain.Therefore, on (b)(6) 2024, the patient was admitted to the hospital due to high blood glucose level of 500 mg/dl and moderate diabetic ketoacidosis.The patient had moderate ketone level.Moreover, the infusion set was changed the same day prior the event.During hospitalization, the patient received fluids insulin intravenously and nutrients as corrective treatment.After spending 3 days in the hospital, the patient was released.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: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18884126
• MDR Text Key: 337414045
• Report Number: 3003442380-2024-00184
• 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: 03/12/2024

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: 5394045
• Initial Date Manufacturer Received: 03/06/2024
• Initial Date FDA Received: 03/12/2024
• Patient Sequence Number: 1