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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 the patient experienced kinked cannula symptoms/issue which were noticed three hours after insertion. His blood glucose level was more than 600 mg/dl. Subsequently, he was taken to the emergency room, and the hospital staff noticed that the cannula was bent, and they used an insulin drip to lower down his blood glucose level. During hospitalization, he was administered fluids of saline, insulin and an unspecified drug intravenously (drug name unknown) as corrective treatment which resolved the issue. He stayed in the emergency room for six days and was admitted in the intensive care unit for four days. 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
MDR Report Key12559515
MDR Text Key274229234
Report Number3003442380-2021-00527
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
K032854
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 Number1001680
Device Lot Number5345422
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2021
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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