MAUDE Adverse Event Report: MIO; UNO INSET II 60/6 SC1 PINK MIMX

Lot Number 5363224

Device Problem Material Twisted/Bent (2981)

Patient Problem Diabetic Ketoacidosis (2364)

Event Type  Injury  

Event Description

Unomedical reference number (b)(4).Foreign: (b)(6).On (b)(6) 2022, it was reported that the patient faced a kinked cannula issue.On (b)(6) 2022, at approximately 1700, she had changed her infusion set but within in two hours started to vomit.Consequently, on (b)(6) 2022, she was admitted to the hospital with blood glucose was reported as 41 mmol/l and ketones as 5 mmol/l (approximately).During hospitalization, she was administered intravenously a drip for hydration and insulin.Reportedly, she also experienced gastroenteritis as well as kinked cannula prior to hospitalization.Further, she has experienced many kinked cannulas of late, when hospitalized.Moreover, the infusion set had already been used for a day and seemed to kink later that day.Moreover, she was hospitalized for four 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 available.

• Brand Name: MIO
• Type of Device: UNO INSET II 60/6 SC1 PINK MIMX
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 14391210
• MDR Text Key: 291601729
• Report Number: 3003442380-2022-00649
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244019942
• UDI-Public: 05705244019942
• 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: 05/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: 5363224
• Date Manufacturer Received: 05/05/2022
• Patient Sequence Number: 1