BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE PRECISIONGLIDE 21X1IN

    MDR report key: 24094594 · Received January 16, 2026

    Report

    Report Number
    3003916417-2026-00018
    Event Type
    Malfunction
    Date Received
    January 16, 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? 4120787 - CM HOSPITALAR MAFRA NF: 1160235 - 3 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? ON (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442707 BD NEEDLE PRECISIONGLIDE 21X1IN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON IND. CIRURGICAS LTDA 5031737 30000078909794

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other