BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE ECLIPSE 25X1-1/2 RB

    MDR report key: 21412535 · Received February 19, 2025

    Report

    Report Number
    2243072-2025-00110
    Event Type
    Malfunction
    Date Received
    February 19, 2025
    Date of Event
    February 3, 2025
    Report Date
    February 7, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903057672
    PMA / PMN Number
    K010188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AS NEITHER A LOT NUMBER NOR A SAMPLE WAS AVAILABLE FOR THIS INCIDENT, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. EXAMINATION OF THE PRODUCT INVOLVED MAY PROVIDE CLARIFICATION AS TO THE CAUSE FOR THE REPORTED FAILURE. COMPLAINTS RECEIVED 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

    IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X1-1/2 RB NEEDLE WAS CLOGGED / BLOCKED. IT WAS REPORTED BY CUSTOMER THAT NEEDLE WOULD NOT DRAW UP OR PUSH OUT WHEN ATTACHED TO THE SYRINGE. NEEDLE BLOCKED. RCC RECEIVED A COMPLAINT VIA EMAIL. NEEDLE WOULD NOT DRAW UP OR PUSH OUT WHEN ATTACHED TO THE SYRINGE. NEEDLE BLOCKED MANUFACTURER PART # 305767 LOT # 111881.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2572559 BD NEEDLE ECLIPSE 25X1-1/2 RB HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON UNKNOWN 00382903057672

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown