MAUDE Adverse Event Report: QUICK SET PARADIGM; UNO QUICK-SET 80/9 SC1 MECA

Lot Number UNKNOWN

Device Problem Material Twisted/Bent (2981)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Event occurred in australia.On 07-mar-2024, it was reported that a patient faced a bent cannula due to which he felt sick, nauseous, vomiting and experienced high blood glucose level of 24 mmol/l.Therefore, on (b)(6) 2024, at 07:00 am, the patient was admitted to the hospital due to diabetic ketoacidosis.Moreover, he was tested for ketone level (7 mmol/l).Further, the patient was admitted to the intensive care unit as he was not feeling well.During hospitalization, the patient received insulin drip intravenously as corrective treatment.After staying for 5 days, the patient was released from the hospital.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 80/9 SC1 MECA
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18892738
• MDR Text Key: 337511313
• Report Number: 3003442380-2024-00190
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244017818
• UDI-Public: 05705244017818
• 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: 03/13/2024

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: UNKNOWN
• Initial Date Manufacturer Received: 03/09/2024
• Initial Date FDA Received: 03/13/2024
• Patient Sequence Number: 1