BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE ECLIPSE 25X5/8

    MDR report key: 20928486 · Received December 13, 2024

    Report

    Report Number
    2243072-2024-01224
    Event Type
    Malfunction
    Date Received
    December 13, 2024
    Date of Event
    November 20, 2024
    Report Date
    November 26, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903057597
    PMA / PMN Number
    K010188
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CURRENT CONTROL, THERE IS A LUER TAPER INSPECTION AT THE MOLDING FIRST PIECE INSPECTION PER MQA-014/AX AND LUER TAPER INSPECTION AT THE ECLIPSE HUB IN-PROCESS INSPECTION PER MFG-043/AA. ACTUAL SAMPLE WAS NOT RECEIVED FOR FURTHER INVESTIGATION. ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT WILL BE RE-OPENED AND RE-INVESTIGATED WHEN SAMPLE IS RECEIVED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE ECLIPSE 25X5/8 SYRINGE NEEDLE CONNECTIVITY ISSUE. IT WAS REPORTED BY CUSTOMER THAT AFTER INJECTION TO PATIENT, NURSE REMOVED NEEDLE FROM THE PATIENT. NURSE ATTEMPTED TO ENGAGE THE SAFETY COVER, AND THE NEEDLE DISCONNECTED FROM THE SYRINGE CAUSING IT TO FLY AND LAND ON THE TOP OF THE OTHER HAND RESULTING IN A NEEDLE STICK TO NURSE. RCC RECEIVED A COMPLAINT VIA EMAIL. AFTER INJECTION TO PATIENT, NURSE REMOVED NEEDLE FROM THE PATIENT. NURSE ATTEMPTED TO ENGAGE THE SAFETY COVER, AND THE NEEDLE DISCONNECTED FROM THE SYRINGE CAUSING IT TO FLY AND LAND ON THE TOP OF THE OTHER HAND RESULTING IN A NEEDLE STICK TO NURSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1859679 BD NEEDLE ECLIPSE 25X5/8 SYRINGE FMI BECTON DICKINSON 3310013 00382903057597

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown