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 by the patient's parent that their son ( a (b)(6) male child patient) had been on the pump for 6 months.Further, they had so many issues and mostly with bent cannulas.He has had about 5 in the last 6 weeks.At the time of one event, he experienced diabetic ketoacidosis and had been admitted for overnight in the intensive care unit.They also stated that it is incredibly dangerous for a cannula to be bent and to not be able to visibly see from the outside.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
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 14600833
• MDR Text Key: 293334734
• Report Number: 3003442380-2022-00726
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 1002817
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 05/26/2022
• Patient Sequence Number: 1