BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRECISIONGLIDE

    MDR report key: 6154215 · Received December 8, 2016

    Report

    Report Number
    6154215
    Event Type
    Malfunction
    Date Received
    December 8, 2016
    Date of Event
    December 5, 2016
    Report Date
    December 5, 2016
    Manufacturer
    BD
    Product Code
    FMI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A STERILE NEEDLE PACKAGE WAS OPENED. THE NEEDLE HAD A LARGE PIECE OF CONTAMINATE ADHERED TO THE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    806432 PRECISIONGLIDE SYRINGES/NEEDLES FMI BD 305197 6152683

    Patients

    Seq Age Sex Outcome Treatment
    1