BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PRECISIONGLIDE NEEDLE 16 G X 1

    MDR report key: 6150761 · Received December 5, 2016

    Report

    Report Number
    MW5066565
    Event Type
    Malfunction
    Date Received
    December 5, 2016
    Date of Event
    December 4, 2016
    Report Date
    December 5, 2016
    Manufacturer
    BD
    Product Code
    FMF
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    BD PRECISIONGLIDE NEEDLE (16G X 1) STERILE NEEDLE WAS NOTED TO HAVE BLACK PARTICLES ON THE SYRINGE TIP AND SHAFT WHEN INSPECTING NEEDLE PRIOR TO USE WHEN IT WAS REMOVED FROM THE OVER-WRAP. IT WAS NOT USED FOR COMPOUNDING SO NO PATIENT WAS POTENTIALLY HARMED, BUT THIS IS AN INSTANCE WHICH COULD INTRODUCE CONTAMINATION TO A COMPOUNDED STERILE PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794926 BD PRECISIONGLIDE NEEDLE 16 G X 1 BD PRECISIONGLIDE NEEDLE 16 G X 1 FMF BD 6152683

    Patients

    Seq Age Sex Outcome Treatment
    1