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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO UNO INSET II 80/6 SC1 GREY MCAN

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MIO UNO INSET II 80/6 SC1 GREY MCAN Back to Search Results
Model Number MMT-965A600
Device Problem Material Twisted/Bent (2981)
Patient Problem Diabetic Ketoacidosis (2364)
Event Type  Injury  
Event Description
Unomedical reference number (b)(4). Event occurred in (b)(6). On (b)(6) 2021, it was reported that the patient experienced high blood glucose levels. Consequently, on (b)(6) 2021 at 10:00 am, the patient was taken to the hospital with blood glucose level of more than 33 mmol/l and the patient experienced diabetic ketoacidosis due to a bent cannula. Reportedly, the bent cannula was noticed after removal of the infusion set. The patient received some unspecified drug intravenously (drug name unknown) as corrective treatment and stayed there overnight. Currently, the patient's blood glucose level was still more than 33 mmol/l. 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 NameMIO
Type of DeviceUNO INSET II 80/6 SC1 GREY MCAN
Manufacturer Contact
aaholmvej 1-3
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lejre, 4320
MDR Report Key12559258
MDR Text Key274229873
Report Number3003442380-2021-00522
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
K160648
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
Report Date 10/01/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/01/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberMMT-965A600
Device Lot Number5313463
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage

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