BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLANT CT SYRINGE KIT

    MDR report key: 5470998 · Received March 1, 2016

    Report

    Report Number
    2520313-2016-00010
    Event Type
    Malfunction
    Date Received
    March 1, 2016
    Date of Event
    February 3, 2016
    Report Date
    February 3, 2016
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    PMA / PMN Number
    K082905
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    BAYER QUALITY ASSURANCE PRODUCT ANALYSIS RECEIVED AND EXAMINED A PHOTOGRAPH OF THE TUBING, LOT # 162065. THE ACTUAL PRODUCT WAS NOT AVAILABLE FOR EXAMINATION. VISUAL INSPECTION OF THE PHOTOGRAPH SHOWS THE PARTICULATE IS PARTIALLY EMBEDDED WITH EXTENSIONS WITHIN THE FLUID PATH. THIS PARTICLE WAS INTRODUCED DURING COMPONENT MANUFACTURING. THE SYRINGE KIT INSTRUCTIONS FOR USE INSTRUCTS THE USER TO "VISUALLY INSPECT CONTENTS AND PACKAGE BEFORE EACH USE". THIS VISUAL INSPECTION IS TO ENSURE PARTICULATES ARE NOTICED AND MITIGATED.

    Additional Manufacturer Narrative · 1

    BAYER QUALITY ASSURANCE PRODUCT ANALYSIS RECEIVED AND EXAMINED THE RETURNED LOW PRESSURE CONNECTING TUBING SET (LPCT), LOT # 162065. THE DEFECT WAS IDENTIFIED AS DEGRADED PLASTIC COMPOUND THAT IS PARTIALLY EMBEDDED IN THE TUBING WALL AND EXTENDS INTO THE FLUID PATHWAY. DYNAMIC FLOW STUDIES WERE PERFORMED ON THE TUBING WITH BOTH SALINE AND CONTRAST MEDIA, CONCLUDING THAT THE EMBEDDED COMPOUND COULD NOT DISLODGE OR FRAGMENT INTO THE FLUID PATH. THE CAUSE OF THE REPORTED PROBLEM IS DEGRADED COMPOUND (RESIN) THAT COLLECTED ON THE EXTRUSION TOOLING AND BECAME PARTIALLY EMBEDDED IN THE TUBING AS IT WAS FORMED DURING MANUFACTURING.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: A BLACK FOREIGN PARTICLE WAS DETECTED INSIDE THE TUBING OF A STELLANT SYRINGE KIT. THIS WAS DETECTED BY THE STAFF AFTER FILLING THE SYRINGE WITH CONTRAST MEDIA AND INJECTING INTO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127137 STELLANT CT SYRINGE KIT ANGIOGRAPHIC SYRINGE KIT DXT BAYER MEDICAL CARE, INC. 3007535 162065

    Patients

    Seq Age Sex Outcome Treatment
    1