MAUDE Adverse Event Report: AUTOSOFT 90; UNO INSET II 60/6 GREY TCAP 10PK INT

Model Number 1002817

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.It was reported that on (b)(6) 2021, (b)(6)-year-old female child patient experienced symptoms due to a kinked cannula.This issue was noticed after more than three hours after insertion on the same day ((b)(6) 2021).Her highest blood glucose level was 590 mg/dl.Which they tried to treat with a correction bolus via pump.Reportedly, she had high ketone level and her health care professional assessed it as dangerous/life threatening.Consequently, she was admitted in the emergency room for one day and was subsequently admitted in the intensive care unit.Her healthcare professional removed the cannula and he stated that it was bent very badly.During hospitalization she was administered fluids of saline, insulin and some unspecified drug intravenously as corrective treatment which resolved the issue.On (b)(6) 2021 she was released from the hospital with no permanent damage.Moreover, they replaced the infusion set and resumed insulin successfully.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: AUTOSOFT 90
• Type of Device: UNO INSET II 60/6 GREY TCAP 10PK INT
• MDR Report Key: 12306603
• MDR Text Key: 265983497
• Report Number: 3003442380-2021-00368
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244018129
• UDI-Public: 05705244018129
• Combination Product (y/n): Y
• PMA/PMN Number: K032854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 07/01/2023
• Device Model Number: 1002817
• Device Lot Number: 5320766
• Date Manufacturer Received: 07/27/2021
• Type of Device Usage: N
• Patient Sequence Number: 1