BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE PRECISIONGLIDE 21X1IN

    MDR report key: 24329832 · Received February 13, 2026

    Report

    Report Number
    3003916417-2026-00030
    Event Type
    Malfunction
    Date Received
    February 13, 2026
    Date of Event
    May 5, 2025
    Report Date
    April 29, 2026
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    UDI-DI
    30000078909794
    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

    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 NEEDLE PRECISIONGLIDE 21X1IN CONTAINED FOREIGN MATTER. BATCH: 5031737 QUANTITY: (B)(4). REASON: 5 DIRTY IN THE PACKAGING AND INSIDE THE NEEDLE, 2 EXTENSIONS IN THE PROTECTIVE COVER PIERCING THE PACKAGING, 1 DEFORMATION IN THE BEVEL, 1 BROKEN, 1 TEAR IN THE PACKAGING BATCH: 4173465 QUANTITY: (B)(4) REASON: 2 INTERNAL DIRT. BATCH: 4204356 QUANTITY: (B)(4) REASON: 3 FOREIGN BODIES INSIDE THE NEEDLE, 2 DIRT INSIDE THE NEEDLE, 2 BROKEN CANNONS, 1 TEAR IN THE PACKAGING. ADDITIONAL INFORMATION RECEIVED ON 02 JAN 2026 BASED ON THE ANALYSIS OF THE PHOTOS YOU PROVIDED, WE IDENTIFIED THE NEW BATCH NUMBER 4120787 WITH THREE ASSOCIATED PHOTOS. COULD YOU CONFIRM FROM WHICH DISTRIBUTOR THIS BATCH WAS PURCHASED? (B)(6):1160235 - (B)(4) UNITS DIRTY IT WAS A BATCH WITHOUT INCLUDING WAS THE INCIDENT REPORTED TO ANVISA? IF SO, WHAT IS THE NOTIFICATION NUMBER? NO, ONLY THE COMPANY. COULD YOU CONFIRM THE DATE ON WHICH THE PROBLEM/DEFECT OCCURRED OR WAS IDENTIFIED? 05/05/2025 ADDITIONAL INFORMATION RECEIVED ON 04 FEB 2026 COULD YOU CLARIFY WHETHER ANY FOREIGN MATTER WAS OBSERVED IN THE SYRINGE'S FLOW PATH? THE DIRT WAS FOUND INSIDE THE SYRINGE, SOME OF IT IS VERY SMALL, BUT DUE TO THE PRESENCE OF A FOREIGN BODY, WE CANNOT RISK USING IT IN HANDLING. I CAN TRY TO IDENTIFY IT FROM THE PHOTOS AND SEND IT TO YOU. I WILL SEND IT FOR CONFIRMATION TOMORROW MORNING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364774 BD NEEDLE PRECISIONGLIDE 21X1IN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON IND. CIRURGICAS LTDA 4204356 30000078909794

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other