BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3ML LL SYR WITH CO-PACKED NEEDLE 26GX3/8"

    MDR report key: 24956945 · Received April 22, 2026

    Report

    Report Number
    1035907-2026-00047
    Event Type
    Malfunction
    Date Received
    April 22, 2026
    Date of Event
    March 13, 2026
    Report Date
    April 21, 2026
    Manufacturer
    EXELINT INTERNATIONAL, CO.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    *THIS ISSUE CANNOT BE FURTHER INVESTIGATED DUE TO THE ABSENCE OF A KNOWN EXEL LOT NUMBER. * NO ADDITIONAL INFORMATION WAS PROVIDED. *THE PRODUCTS IN QUESTION WERE NOT RETURNED FOR INVESTIGATION. *NO DOCUMENTARY EVIDENCE SUCH AS PHOTOS OR VIDEOS WERE PROVIDED WITH THIS COMPLAINT. *DUE TO THE LACK OF EVIDENCE NOR LOT NUMBER THIS COMPLAINT CAN NOW BE CLOSED. *TO ADDRESS THIS PROACTIVELY, *WE WILL CONTINUOUSLY REVIEW AND MONITOR THIS TYPE OF COMPLAINT. *THIS INCIDENT WILL BE ADDED TO OUR LIST OF COMPLAINTS FOR TRACKING AND TREND ANALYSIS. *WE WILL WORK TO IMPROVE COMMUNICATION AND COLLABORATION WITH TANDEM TO ENHANCE DATA COLLECTION AND GATHERING PROCESS. (B)(4).

    Description of Event or Problem · 0

    ISSUE: CALLER REPORTED NEEDLE DAMAGE: "NEEDLE OR SYRINGE 'EXPLODING' WHILE HE WAS ATTEMPTING TO LOAD A CARTRIDGE AND THE INSULIN SUBSEQUENTLY GETTING IN HIS EYE" INJURY: THERE WAS NO REPORTED INJURY OR CONSEQUENCES FROM CALLER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272929 3ML LL SYR WITH CO-PACKED NEEDLE 26GX3/8" SYRINGE WITH NEEDLE FMF EXELINT INTERNATIONAL, CO.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown