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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 faced a bent cannula and he experienced high blood glucose level.Therefore, they tried to treat by changing the infusion sets, but on (b)(6) 2024, the patient first went to emergency room and was subsequently admitted to the hospital due to high blood glucose level.His highest blood glucose level ranged between 600-625 mg/dl and had high ketone level which the healthcare professional did not assessed as dangerous or life-threatening.Moreover, the infusion set was used for one day.During hospitalization, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown)intravenously as corrective treatment which resolved the issue.At the time of this report, the patient was not released from the hospital.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 was available.
 
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Brand Name
INFUSION DEVICES - UNKNOWN
Type of Device
INFUSION DEVICES - UNKNOWN
Manufacturer Contact
aaholmvej 1-3
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lejre, 4320
MDR Report Key18893217
MDR Text Key337520393
Report Number3003442380-2024-00187
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Distributor
Reporter Occupation Other
Type of Report Initial
Report Date 03/13/2024
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
Device Lot NumberUNKNOWN
Initial Date Manufacturer Received 03/08/2024
Initial Date FDA Received03/13/2024
Patient Sequence Number1
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