BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISIONGLIDE NEEDLE 16 G X 1

    MDR report key: 8089740 · Received November 19, 2018

    Report

    Report Number
    MW5081473
    Event Type
    Malfunction
    Date Received
    November 19, 2018
    Date of Event
    November 15, 2018
    Report Date
    November 15, 2018
    Manufacturer
    BD
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    BD 16GX1" PRECISIONGLIDE NEEDLE [REFERENCE 305197; LOT 8143717 EXP 7/31/2023] HAD WHITE PARTICULATE MATTER WITHIN NEEDLE COVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923237 PRECISIONGLIDE NEEDLE 16 G X 1 NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BD 305197 8143717

    Patients

    Seq Age Sex Outcome Treatment
    1