BEUDAMED
    FDA Adverse Event Summary report: N

    *

    MDR report key: 3042168 · Received March 28, 2013

    Report

    Report Number
    3042168
    Date Received
    March 28, 2013
    Date of Event
    March 27, 2013
    Report Date
    March 27, 2013
    Manufacturer
    MEDLINE INDUSTRIES, INC.
    Product Code
    FMF
    Report Source
    User Facility report
    Reporter Location
    MT, US

    Narratives

    Description of Event or Problem · 1

    WHEN GOING TO DRAW UP ANESTHETIC FOR PROCEDURE IN A STERILE FIELD, PHYSICIAN NOTICED A FOREIGN OBJECT IN THE 10 ML SYRINGE. THIS FOREIGN OBJECT APPEARED TO BE A HAIR, BUT THAT WAS NOT CONFIRMED.======================MANUFACTURER RESPONSE FOR CORE BIOPSY TRAY - 10ML SYRINGE, MEDLINE (PER SITE REPORTER).======================WHAT WAS THE ORIGINAL INTENDED PROCEDURE?THYROID.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    128087 * SYRINGE, PISTON FMF MEDLINE INDUSTRIES, INC. * 12KD2626

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR