BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INFUSION DEVICES - UNKNOWN

    MDR report key: 19686034 · Received July 7, 2024

    Report

    Report Number
    3003442380-2024-12709
    Event Type
    Injury
    Date Received
    July 7, 2024
    Date of Event
    June 4, 2024
    Report Date
    January 26, 2026
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL AND FINAL MDR 1905812 - MDR 3003442380-2024-12709 - DEVICE 4 OF 11 (B)(6).

    Description of Event or Problem · 0

    UNOMEDICAL REFERENCE NUMBER (B)(4). EVENT OCCURRED IN (B)(6). . ON (B)(6) 2024, IT WAS REPORTED THAT THE PATIENT FACED INFUSION SET CANNULA WAS BENT ON THE INSERTION SITE AT ABDOMEN, WHICH CAUSED THE PATIENT BLOOD GLUCOSE ELEVATED TO 234 MG/DL, WHICH RESULTS THAT THE PATIENT HAD VOMITING AND DIARRHEA. THE PATIENT WAS IN EMERGENCY ROOM FOR 24 HOURS AND FURTHER SUBSEQUENTLY GOT HOSPITALIZED DUE TO DIABETIC KETOACIDOSIS. THE PATIENT ALSO HAD KETONES 3.9 MMOL/L. THE INFUSION SET WAS IN USE FOR MORE THAN 24 HOURS. 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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901184 INFUSION DEVICES - UNKNOWN INFUSION DEVICES - UNKNOWN FPA UNOMEDICAL A/S UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H