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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, 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.
 
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Brand NameAUTOSOFT XC
Type of DeviceUNO INSET I 60/6 GREY TCAP 10PK INT
Manufacturer Contact
aaholmvej 1-3
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lejre, 4320
MDR Report Key14390050
MDR Text Key291598419
Report Number3003442380-2022-00645
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
Type of Report Initial
Report Date 05/13/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/13/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Model Number1001680
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Date Manufacturer Received05/03/2022
Was Device Evaluated by Manufacturer? No Answer Provided

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