BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE

    MDR report key: 25321933 · Received May 28, 2026

    Report

    Report Number
    3003916417-2026-00080
    Event Type
    Malfunction
    Date Received
    May 28, 2026
    Date of Event
    April 27, 2026
    Report Date
    May 28, 2026
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST
    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. THIS REPORT IS SUPPLEMENTAL TO PREVIOUSLY SUBMITTED 2243072-2026-00360. IT HAS BEEN DETERMINED THAT THE LEGAL MANUFACTURER IS CURITIBA. THIS NEW MDR IS BEING SUBMITTED TO CORRECT THE LEGAL SITE AND TO SUBMIT A MDR UNDER THE CORRECT SITE REGISTRATION NUMBER. A CORRECTION SUPPLEMENTAL HAS BEEN SUBMITTED FOR 243072-2026-0036.

    Description of Event or Problem · 0

    THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT DIRT WAS FOUND INSIDE THE NEEDLE DURING HANDLING. DISPOSABLE NEEDLE 40X12 S DISP SEG. EXPIRY DATE: 31/10/2030. LOT: SAGAAB051D. INVOICE NUMBER: (B)(4). SAMPLE AVAILABLE. THE SAMPLE WILL ONLY BE TAKEN IF THE PRODUCT IS EXCHANGED. AFTER 60 DAYS OF NOTIFICATION, THE SAMPLE WILL BE DISCARDED. SAMPLE COLLECTION TIMES: MONDAY TO FRIDAY, FROM 8AM TO 4PM. ADDITIONAL INFORMATION PROVIDED: MATERIAL NUMBER WAS IDENTIFIED AS 300017 ON 05/18/2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    160924 BD NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON IND. CIRURGICAS LTDA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1