BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    150 FASTURN SYRINGE KIT W/QFT

    MDR report key: 3811110 · Received March 24, 2014

    Report

    Report Number
    2520313-2014-00020
    Event Type
    Malfunction
    Date Received
    March 24, 2014
    Date of Event
    February 24, 2014
    Report Date
    February 24, 2014
    Manufacturer
    BAYER MEDICAL CARE, INC
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAYER R & I PRODUCT ANALYSIS RECEIVED AND EXAMINED THE 150 - FT SYRINGE, (LOT # 153313) AND CONFIRMED THE PRESENCE OF A PARTICULATE IN THE FLUID PATH. THE PARTICLE MEASURED APPROX 2.25MM LONG BY 0.75MM WIDE. THE PARTICLE HAS THE POTENTIAL TO FRAGMENT AND BREAK APART; THEREFORE, THE POTENTIAL TO BE INJECTED INTO THE PT EXISTS. THE FASTURN SYRINGE INSTRUCTION FOR USE (IFU) STATES: VISUALLY INSPECT CONTENTS AND PACKAGE BEFORE EACH USE. IN THE EVENT ADDITIONAL INFO IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: A PIECE OF PLASTIC WAS NOTICED INSIDE A SYRINGE. VISUAL INSPECTION OF THE SYRINGE PRIOR TO USE PREVENTED THE PRODUCT FROM BEING USED FOR A PT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    172790 150 FASTURN SYRINGE KIT W/QFT ANGIOGRAPHIC SYRINGE KIT DXT BAYER MEDICAL CARE, INC 3026767 153313

    Patients

    Seq Age Sex Outcome Treatment
    1