BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE PRECISIONGLIDE 21X1IN

    MDR report key: 24606829 · Received March 16, 2026

    Report

    Report Number
    3003916417-2026-00042
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    November 25, 2025
    Report Date
    March 16, 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-AI2-SM2 NEEDLE PRECISIONGLIDE 21X1IN NEEDLE WAS BROKEN. PRODUCT: NEEDLE 0.80X25MM (21GX1'') LOT: 5120729 - 1 UNIT 1 NEEDLE WITH HOLE IN THE PACKAGE. CORRIDO DATE: (B)(6) 2025. LOT: 4204356 - 1 UNIT 1 BROKEN NEEDLE CORRIDO DATE: (B)(6) 2025. LOT: 5150655 - 1 UNIT 1 DEFORMED TIP OF THE NEEDLE CAP. CORRIDO DATE: (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    205942 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