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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AUTOSOFT XC; UNO INSET I 60/6 GREY TCAP 10PK INT
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AUTOSOFT XC; UNO INSET I 60/6 GREY TCAP 10PK INT Back to Search Results
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 and (b)(6) 2022, a fifteen-year-old male child patient experienced kinked cannula symptoms/issue were noticed after three hours of insertion.His highest blood glucose level was 650 mg/dl and had high/ large ketones.However, the health care professional assessed the ketone level as not dangerous/life threatening.The infusion set had been used for 5 hours to 1 and a half days.Subsequently, they went to the hospital where the patient was administered an unknown medication (drug name unknown) intravenously.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.
 
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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 Key14742051
MDR Text Key294518077
Report Number3003442380-2022-00773
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05705244016620
UDI-Public05705244016620
Combination Product (y/n)Y
PMA/PMN Number
K032854
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 06/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/20/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number1001680
Device Lot NumberUNKNOWN
Date Manufacturer Received06/07/2022
Patient Sequence Number1
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