BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLANT CT SYRINGE KIT

    MDR report key: 4212928 · Received August 4, 2014

    Report

    Report Number
    2520313-2014-00040
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    June 30, 2014
    Report Date
    July 9, 2014
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    PMA / PMN Number
    K082905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAYER RADIOLOGY QUALITY ASSURANCE PRODUCT ANALYSIS RECEIVED AND EXAMINED THE RETURNED LOW PRESSURE CONNECTING TUBING (LPCT), FROM SYRINGE KIT SJS-PT-J, LOT# 149609, AND IDENTIFIED THE PRESENCE OF A BLACK PARTICLE IN THE FLUID PATH. THE PARTICULATE WAS EMBEDDED WITHIN THE WALL OF THE TUBING MATERIAL EXTENSIONS THAT COULD POTENTIALLY FRAGMENT WHILE UNDER PRESSURES TYPICALLY GENERATED DURING AN INJECTION. THE PARTICULATE MEASURED APPROX 8.0 MM X 0.5 MM. COMPARISON OF THE PARTICULATE WITH INSIDE DIAMETER OF THE RANGE OF CATHETERS USED FOR RADIOLOGY INJECTION CONCLUDED THAT THE POTENTIAL OF INJECTION OF THIS SIZE PARTICULATE INTO THE PATIENT EXISTS. THE SYRINGE KIT INSTRUCTIONS FOR USE (202033 REV S) INSTRUCTS THE USER TO "VISUALLY INSPECT CONTENTS AND PACKAGE BEFORE EACH USE". THIS VISUAL INSPECTION IS TO ENSURE PARTICULATES ARE NOTICED AND MITIGATED, WHICH IS WHAT OCCURRED IN THIS REPORTED INSTANCE. IN THE EVENT ADDITIONAL INFO IS RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: A BLACK FOREIGN SUBSTANCE WAS VISUALIZED IN THE CT CONNECTING TUBE PRIOR TO USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455520 STELLANT CT SYRINGE KIT ANGIOGRAPHIC SYRINGE KIT DXT BAYER MEDICAL CARE, INC. 3010860 149609

    Patients

    Seq Age Sex Outcome Treatment
    1