BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SER PLAS 1ML 13X3,8 U-100 150

    MDR report key: 25167702 · Received May 14, 2026

    Report

    Report Number
    3003916417-2026-00074
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    April 29, 2026
    Report Date
    May 4, 2026
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD EVA-AI3-SM3 SER PLAS 1ML 13X3,8 U-100 150 CONTAINED FOREIGN MATTER. VERBATIM: "WE FOUND A UNIT OF THE 1ML SYRINGE WITH NEEDLE IN OUR STOCK WITH DIRT ON ITS PACKAGING. THE PACKAGING HAD NOT BEEN OPENED, WAS SEALED AND IS BEING KEPT WITH US FOR COLLECTION IF NECESSARY. I REQUEST AN INVESTIGATION AND AWAIT INSTRUCTIONS." PRODUCT: 1ML SYRINGE WITH NEEDLE 0.38X13MM (27.5G X 1/2") LUER SLIP REF. 990147 LOT: 4297793 EXPIRY DATE: 11/2029 MANUFACTURE: 11/2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627287 BD SER PLAS 1ML 13X3,8 U-100 150 PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 4297793

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other