BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 24945518 · Received April 21, 2026

    Report

    Report Number
    1035907-2026-00046
    Event Type
    Injury
    Date Received
    April 21, 2026
    Date of Event
    March 17, 2026
    Report Date
    April 20, 2026
    Manufacturer
    EXELINT INTERNATIONAL, CO.
    Product Code
    FMF
    UDI-DI
    20020221012150
    PMA / PMN Number
    K861153
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    *THIS LOT WAS INVESTIGATED IN IR # 20260224. *RETAINED SAMPLES WERE TESTED AND ANALYZED FOR VISUAL INSPECTION, SIMULATED SUCTION, SIMULATED INJECTION, OBSERVATION UNDER STATIC CONDITIONS, AS WELL AS REVIEW OF FACTORY INSPECTION DATA. ALL SAMPLES TESTED AND ANALYZED PASSED ALL INSPECTIONS AND WERE DEEMED QUALIFIED, WITH NO QUALITY DEFECTS OBSERVED. * ALL RELEVANT DOCUMENTS ( BATCH PRODUCTION RECORDS, FINISHED PRODUCT INSPECTION, PROCESS CONTROL, INCOMING INSPECTION, INSPECTION AND TESTING) CORRESPONDING TO THE TESTED LOT WERE CAREFULLY REVIEWED AND FOUND TO COMPLY WITH PRODUCT RELEASE REQUIREMENTS, WITH NO ABNORMALITIES FOUND. *THE INCOMING INSPECTION FOR THIS WAS PERFORMED IN ACCORDANCE TO SOP-11 INCOMING INSPECTION PROCEDURE. THESE LOTS PASSED THE ACCEPTANCE CRITERIA FOR PRODUCT RELEASE, WITH NO ABNORMALITIES DETECTED. *FOR THIS LOT THE ISSUES HAVE BEEN INVESTIGATED, AND NO DEVICE ISSUES HAVE BEEN FOUND ANY COMPLAINTS FOR THE SAME ISSUES. *THE PRODUCTS IN QUESTION WERE NOT RETURNED FOR INVESTIGATION. *NO DOCUMENTARY EVIDENCE SUCH AS PHOTOS OR VIDEOS WERE PROVIDED WITH THIS COMPLAINT. *BASED ON AVAILABLE INFORMATION AND MANUFACTURING INVESTIGATION, NO DEVICE PROBLEM HAS BEEN FOUND. 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, AND WE WILL WORK TO IMPROVE COMMUNICATION AND COLLABORATION WITH TANDEM TO ENHANCE DATA COLLECTION AND GATHERING PROCESS. *NO SIMILAR COMPLAINTS WITHIN THE LOT. (B)(4).

    Description of Event or Problem · 0

    ISSUE: CALLER REPORTED NEEDLE DAMAGE: "NEEDLE EXPLODED OFF OF SYRINGE WHEN TRYING TO PUSH AIR OUT FROM SYRINGE AFTER REMOVING AIR FROM CARTRIDGE" INJURY: THERE WERE NO INJURY OR CONSEQUENCES FROM CALLER. RESOLUTION: REPLACEMENT OF NEEDLE AND/OR SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    479443 3ML LL SYR WITH CO-PACKED NEEDLE 26GX3/8'' SYRINGE WITH NEEDLE FMF EXELINT INTERNATIONAL, CO. 250523 20020221012150

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown