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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: INFUSION DEVICES - UNKNOWN

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INFUSION DEVICES - UNKNOWN Back to Search Results
Lot Number UNKNOWN
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. On (b)(6) 2021, the patient's mother reported that her daughter faced a bent cannula due to which she experienced diabetic ketoacidosis. Therefore, on (b)(6) 2021, the patient was admitted in the hospital, where she received intravenous insulin infusion as corrective treatment. The patient was admitted in the hospital for two 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 NameINFUSION DEVICES - UNKNOWN
Type of DeviceINFUSION DEVICES - UNKNOWN
Manufacturer Contact
aaholmvej 1-3
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lejre, 4320
MDR Report Key12517910
MDR Text Key272856660
Report Number3003442380-2021-00496
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor
Type of Report Initial
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/23/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/15/2021
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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