MAUDE Adverse Event Report: QUICK-SET® PARADIGM®; UNO QUICK-SET 80/6 SC1 MECA

Model Number MMT-387A

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 (b)(6) 2022, it was reported that the patient felt nauseous/vomiting and experienced high blood glucose level due to a bent cannula.The site location was patient's abdomen and the infusion had been used for few hours.Therefore, on (b)(6) 2022, at 19:00 hours, the patient was admitted to the hospital.The patient had ketone level.During hospitalization, the patient received insulin drip intravenously as corrective treatment.After staying for five 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 available.

• Brand Name: QUICK-SET® PARADIGM®
• Type of Device: UNO QUICK-SET 80/6 SC1 MECA
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 15481860
• MDR Text Key: 300586132
• Report Number: 3003442380-2022-01036
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244017696
• UDI-Public: 05705244017696
• Combination Product (y/n): Y
• 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: 09/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: MMT-387A
• Device Lot Number: 5372601
• Date Manufacturer Received: 09/14/2022
• Patient Sequence Number: 1