BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TANDEM DIABETES 3ML LL SYR WITH CO-PACKED NEEDLE 26GX3/8''

    MDR report key: 23230106 · Received October 6, 2025

    Report

    Report Number
    1035907-2025-00036
    Event Type
    Malfunction
    Date Received
    October 6, 2025
    Date of Event
    September 8, 2025
    Report Date
    October 3, 2025
    Manufacturer
    EXELINT INTERNATIONAL CO.
    Product Code
    FMF
    PMA / PMN Number
    K861153
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). - LOT NUMBER WAS NOT PROVIDED AND NO FURTHER INFORMATION IS AVAILABLE; THEREFORE FURTHER INVESTIGATION IS NOT POSSIBLE.

    Description of Event or Problem · 0

    CALLER REPORTED, "NEEDLE AND NEEDLE HUB CAME OUT OF THE SYRINGE WHILE FILLING CARTRIDGE". INSULIN GOT INTO PATIENTS EYE, BUT NO MEDICAL INTERVENTION WAS NEEDED. CUSTOMER WASHED OUT EYE IMMEDIATELY. THE RESOLUTION WAS A CHANGE OF THE SYRINGE AND NEEDLE TO SUCCESSFULLY FILLED A CARTRIDGE WITH INSULIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1422594 TANDEM DIABETES 3ML LL SYR WITH CO-PACKED NEEDLE 26GX3/8'' SYRINGE WITH NEEDLE FMF EXELINT INTERNATIONAL CO. 1001215

    Patients

    Seq Age Sex Outcome Treatment
    1 16 YR Female Other