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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 the patient was admitted to the hospital for 2 days on unknown dates in (b)(6) 2020, as her cannula had not inserted into her skin correctly, so she was not receiving insulin due to a bent cannula. Reportedly, to treat the high blood glucose level, she bolused via the pump. Consequently, she went to the emergency room and was subsequently hospitalized due to a bent cannula. During hospitalization, she was administered insulin injections as corrective treatment which resolved the issue and was released with no permanent damage. It was stated that the infusion set had been used for three days. Moreover, she was again admitted to the hospital for 6 days on unknown dates (arrived in the hospital on an unknown sunday and was released on an unknown friday) in (b)(6) 2021. For this instance, she experienced high blood glucose level (600 mg/dl) and went into diabetic ketoacidosis because of a bent cannula. 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 Key11869206
MDR Text Key252388048
Report Number3003442380-2021-00257
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 Received05/24/2021
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 Received05/18/2021
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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