BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD ECLIPSE NEEDLE 25G X 1 INCH NEEDLE TIP

    MDR report key: 8253973 · Received January 15, 2019

    Report

    Report Number
    MW5083184
    Event Type
    Malfunction
    Date Received
    January 15, 2019
    Report Date
    January 13, 2019
    Manufacturer
    BD
    Product Code
    FMI
    UDI-DI
    08290305761
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    THERE WAS BLACK PARTICULATE MATTER IN THE ORANGE PART OF BD ECLIPSE NEEDLE TIP 25G X 1 INCH. NDC #(B)(4). LOT # 8171376 EXP 06/30/2023. I NOTICED THIS RIGHT BEFORE I SCREWED IT ONTO A VACCINE. I DISCARDED IT AND GOT A NEW NEEDLE TIP. I CONTACTED THE MANUFACTURER ON (B)(6) 2019 AND WAS TOLD THEY WOULD SEND ME A PRE-PAID LABEL TO SEND PRODUCT BACK SO THEY COULD INVESTIGATE THE PROBLEM BUT THAT NEVER HAPPENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44442 BD ECLIPSE NEEDLE 25G X 1 INCH NEEDLE TIP NEEDLE HYPODERMIC SINGLE LUMEN FMI BD 8171376 08290305761

    Patients

    Seq Age Sex Outcome Treatment
    1