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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. It was reported that a (b)(6)-year-old female child patient faced a kinked cannula due to which she experienced high blood glucose level on an unknown date between (b)(6) 2021 to (b)(6) 2021. Therefore, they tried to treat it with multiple daily injection, but on an unknown date, the patient went to the emergency room. Her highest blood glucose level was 400 mg/dl and had high ketone levels which was not assessed as dangerous/life threatening by the healthcare professional. During her stay in the emergency room, she received fluids of saline, insulin and an unspecified medication (drug name unknown) as corrective treatment which resolved the issue. She stayed in the emergency room for eight hours and on the same unknown date (date of admission in the emergency room) she was discharged. Moreover, she faced a kinked cannula symptoms/issue noticed after three hours of insertion on an unknown date between (b)(6) 2021 and (b)(6) 2021. The patient's blood glucose level was 400 mg/dl at the time of the event. Further, they replaced the infusion set and insulin was resumed successfully. 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
osted
lejre, 4320
MDR Report Key12517848
MDR Text Key272856881
Report Number3003442380-2021-00492
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 Received09/14/2021
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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