BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE

    MDR report key: 24808171 · Received April 7, 2026

    Report

    Report Number
    3002682307-2026-00034
    Event Type
    Malfunction
    Date Received
    April 7, 2026
    Date of Event
    March 27, 2026
    Report Date
    May 11, 2026
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    003

    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 THE BD NEEDLE NS 23G 1IN HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT DURING ASSEMBLY, ONE ITEM OF MATERIAL: 304627 - 300800, BATCH: 5062066 WAS FOUND WITH A HAIR. THIS CONCERNS: MATERIAL: 300043756, XREF: 304627 - 300800, DESCRIPTION: NEEDLE,23GX1IN, BATCH: 5062066, QTY (EA): 1, INTERNAL ALB NOTIFICATION: (B)(4). WE KINDLY ASK YOU TO INVESTIGATE THE CAUSE OF THIS ISSUE IN THE SPECIFIED BATCH AND PROVIDE CORRECTIVE AND PREVENTIVE ACTIONS. A SAMPLE IS AVAILABLE IF REQUESTED. THANK YOU FOR YOUR SUPPORT. PLEASE DON'T HESITATE TO REACH OUT IF ADDITIONAL INFORMATION IS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65686 BD NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON, S.A. 5062066

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown