MAUDE Adverse Event Report: INFUSION DEVICES - UNKNOWN

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 due to which he experienced high blood glucose level.Therefore, they tried to treat it with multiple daily injection, but on (b)(6) 2024, he first went to the emergency room and was subsequently hospitalized due to high blood glucose level.Further, the patient was transferred to the intensive care unit (three days).His highest blood glucose level was over 600 mg/dl and ketone level was high.The patient's liver was damaged and he had diabetic ketoacidosis.Moreover, the infusion had been used for three days.During hospitalization, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue after three days.On (b)(6) 2024, the patient was released from the hospital with no permanent damage.Previously, in the beginning of the year 2023, the patient faced a bent cannula and he experienced high blood glucose level.Therefore, on an unknown date, he first went to the emergency room and was subsequently hospitalized due to high blood glucose level.His highest blood glucose level ranged from 600-700 mg/dl.Moreover, the infusion had been used for three days.During hospitalization, the patient received fluids of saline, insulin, and unspecified medication (drug name unknown) intravenously as corrective treatment which resolved the issue.On an unknown date, the patient was released from the hospital with no permanent damage.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.

• Brand Name: INFUSION DEVICES - UNKNOWN
• Type of Device: INFUSION DEVICES - UNKNOWN
• Manufacturer Contact: aaholmvej 1-3; osted; lejre, 4320
• MDR Report Key: 18918829
• MDR Text Key: 337844833
• Report Number: 3003442380-2024-00192
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/13/2024
• Patient Sequence Number: 1