BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3CC LUER LOCK SYRINGE (LOW DEAD SPACE PLUNGER)

    MDR report key: 24211265 · Received January 29, 2026

    Report

    Report Number
    MW5183032
    Event Type
    Malfunction
    Date Received
    January 29, 2026
    Date of Event
    January 23, 2026
    Manufacturer
    EXELINT INTERNATIONAL, CO.
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    PATIENT
    Health Professional
    *

    Narratives

    Description of Event or Problem · 0

    ON FRIDAY, (B)(6) AT APPROXIMATELY 9:30AM MST, I DISCOVERED A DEAD INSECT SEALED INSIDE THE STERILE PACKAGING OF AN UNOPENED SYRINGE. THE STERILE SLEEVE WAS INTACT AND HAD NOT BEEN OPENED. THE DEVICE IS AN EXEL 3CC LUER LOCK SYRINGE (LOW DEAD SPACE PLUNGER), REF #26200, LOT #240924. THE SYRINGE WAS PURCHASED AS PART OF A 50-PACK FROM (B)(4) MEDICAL SUPPLIES ON (B)(6) 2025 (ORDER #(B)(4)). THE SYRINGES WERE STORED IN AN ACRYLIC DRAWER UNDER THE SINK IN MY BATHROOM SINCE RECEIPT. THERE WAS NO EXPOSURE OR HANDLING THAT COULD EXPLAIN THE PRESENCE OF A FOREIGN INSECT INSIDE SEALED STERILE PACKAGING. THE DEVICE WAS NOT USED. CLEAR PHOTOGRAPHIC EVIDENCE AND AN UNCUT VIDEO DOCUMENT THE FOREIGN INSECT VISIBLE INSIDE THE UNOPENED STERILE SLEEVE. THIS REPRESENTS A STERILITY BREACH AND MANUFACTURING OR PACKAGING DEFECT IN A MEDICAL DEVICE INTENDED FOR INJECTION USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    268096 3CC LUER LOCK SYRINGE (LOW DEAD SPACE PLUNGER) SYRINGE, PISTON FMF EXELINT INTERNATIONAL, CO. 240924

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR Male ANASTROZOLE.| TESTOSTERONE CYPIONAT.