MAUDE Adverse Event Report: AUTOSOFT¿ XC; UNO INSET I 60/6 GREY TCAP 10PK INT

Model Number 1001680

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 the patient experienced kinked cannula issue and it was noticed after more than three hours after insertion.Reportedly, this issue occurred with one infusion set on (b)(6) 2021 and her blood glucose level was above 600 mg/dl.Consequently, on (b)(6) 2021, she was admitted in the emergency room for three days and was subsequently shifted to the intensive care unit.Further, the infusion set was used for thirteen hours.During hospitalization, she was administered fluids of saline, insulin, and an unknown medication intravenously (drug name unknown) which resolved the issue.But she got bruising (injury) from intravenous insertion.On (b)(6) 2021, she was released from the hospital with no permanent damage.Moreover, the same issue occurred with six infusion sets on (b)(6) 2021 and her blood glucose level was reported to be 100-120 mg/dl.Furthermore, the patient 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¿ XC
• Type of Device: UNO INSET I 60/6 GREY TCAP 10PK INT
• MDR Report Key: 12459340
• MDR Text Key: 270995530
• Report Number: 3003442380-2021-00462
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 05705244016620
• UDI-Public: 05705244016620
• 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: 09/13/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 02/01/2024
• Device Model Number: 1001680
• Device Lot Number: 5338630
• Date Manufacturer Received: 09/02/2021
• Type of Device Usage: N
• Patient Sequence Number: 1