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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MIO; UNO INSET II 60/6 SC1 PINK MCAN
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MIO; UNO INSET II 60/6 SC1 PINK MCAN Back to Search Results
Model Number MMT-923A600
Medical Device Problem Code Material Twisted/Bent (2981)
Health Effect - Clinical Code Elevated ketones/Diabetic Ketoacidosis (2364)
Type of Reportable Event Serious Injury
Event or Problem Description
Unomedical reference number (b)(4).Event occurred in (b)(6).On (b)(6)2021, the patient's mother reported that the patient faced a bent cannula.Therefore, the patient went to the emergency room and was subsequently hospitalized, where she received insulin drip intravenously as corrective treatment.Reportedly, the site location was patient's abdomen and the infusion had been used for two days.The patient was hospitalized overnight.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
MIO
Common Device Name
UNO INSET II 60/6 SC1 PINK MCAN
MDR Report Key11691986
Report Number3003442380-2021-00218
Device Sequence Number3511500
Product Code FPA
UDI-Device Identifier05705244020245
UDI-Public05705244020245
Combination Product (Y/N)Y
PMA/510(K) Number
K160648
Number of Events Summarized1
Summary Report (Y/N)N
Serviced by Third Party (Y/N)Unknown
Reporter Type Manufacturer
Report Source distributor
Initial Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device No Information
Device Expiration Date12/01/2022
Device Model NumberMMT-923A600
Device Lot Number5304724
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/09/2021
Initial Report FDA Received Date04/20/2021
Patient Sequence Number1
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