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 on (b)(6) 2022, a (b)(6) year-old female child patient faced a kinked cannula.The infusion set had been used for two days.Reportedly, a white line was formed on cannula indicating that the cannula was bent at 90 degrees and the symptoms/issue was noticed after three hours of insertion.At the time of the event, her blood glucose level was 600 mg/dl and consequently, she was taken to the hospital after changing the infusion set.Moreover, she had high/large ketones, but her health care professional did not assess it as dangerous/ life threatening.Moreover, they replaced the infusion set and resumed insulin successfully.However, it was stated that the infusion set was kinked not a bend.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
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 14390050
• MDR Text Key: 291598419
• Report Number: 3003442380-2022-00645
• 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
• 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 Model Number: 1001680
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 05/03/2022
• Patient Sequence Number: 1