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

Lot Number 5341363

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 (b)(6).On (b)(6) 2021, it was reported by a nurse that a (b)(6) year-old male child patient experienced two bent cannula issues which led to high blood glucose level in the 20's mmol/l.Reportedly, he had high blood glucose level, had ketones and very nearly diabetic ketoacidosis.Consequently, on an unknown date, he was admitted to the hospital and was treated with injections.Moreover, he was in the hospital for four days now (on the date of this report).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 BLUE MIMX
• MDR Report Key: 12604520
• MDR Text Key: 276115772
• Report Number: 3003442380-2021-00565
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244020030
• UDI-Public: 05705244020030
• 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
• Type of Report: Initial
• Report Date: 10/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 11/01/2023
• Device Lot Number: 5341363
• Date Manufacturer Received: 09/23/2021
• Type of Device Usage: N
• Patient Sequence Number: 1