BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE

    MDR report key: 21322573 · Received February 6, 2025

    Report

    Report Number
    2243072-2025-00054
    Event Type
    Malfunction
    Date Received
    February 6, 2025
    Date of Event
    January 22, 2025
    Report Date
    January 27, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. D.3. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. E.1. ADDRESS WAS NOT LOCATED AND IL WAS USED. G.1. FRANKLIN LAKES HAS BEEN LISTED AS THE MANUFACTURER. AS NO PHYSICAL SAMPLE, VALID PART NUMBER OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE CONFIRMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR QUALITY TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    MATERIAL #:UNKNOWN, BATCH#:UNKNOWN. IT WAS REPORTED BY CUSTOMER THAT THE 5 ML ORAL DOSING SYRINGE IDENTIFIED WITH OVERDOSING. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. "SPIEGEL, G.J., ET AL., DESIGN, EVALUATION, AND DISSEMINATION OF A PLASTIC SYRINGE CLIP TO IMPROVE DOSING ACCURACY OF LIQUID MEDICATIONS. ANN BIOMED ENG, 2013. 41(9): P. 1860-8. UNITED STATES AND MALAWI".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632221 BD SYRINGE PISTON SYRINGE FMF BECTON DICKINSON UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown