BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STELLANT SYRINGE KIT

    MDR report key: 2960395 · Received January 25, 2013

    Report

    Report Number
    2520313-2013-00005
    Event Type
    Malfunction
    Date Received
    January 25, 2013
    Date of Event
    December 27, 2012
    Report Date
    December 28, 2012
    Manufacturer
    MEDRAD
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAYER R AND I PRODUCT ANALYSIS RECEIVED AND EXAMINED THE RETURNED TUBING ASSEMBLY, LOT NUMBER 122919, AND IDENTIFIED THE PRESENCE OF DEGRADED RESIN IN THE FLUID PATH. THE RESIN, WHICH WAS APPROXIMATELY 1.75 X 0.50 MM IN SIZE, WAS DETECTED ABOUT 8 INCHES FROM THE DISTAL (PATIENT SIDE) PORT OF THE TUBING ASSEMBLY AFTER BEING REMOVED FROM THE SYRINGE KIT. COMPARISON OF THE WIDTH OF THE PARTICLE WITH THE INSIDE DIAMETER OF THE RANGE OF CATHETERS USED FOR RADIOLOGY PROCEDURES CONCLUDED THAT THE PARTICLE HAD THE POTENTIAL TO PASS THROUGH THE CATHETER TO THE PATIENT. ALTHOUGH THE PARTICLE WAS CONNECTED TO THE INSIDE WALL OF THE TUBING, FORCE FROM FLUID FLOW DURING AN INJECTION COULD HAVE DISLODGED THE PARTICLE. THE SYRINGE KIT INSTRUCTIONS FOR USE INSTRUCTS THE CUSTOMER TO "VISUALLY INSPECT CONTENTS AND PACKAGE BEFORE EACH USE". THIS VISUAL INSPECTION ENSURES ANY PARTICULATES ARE NOTICED AND MITIGATED, WHICH IS WHAT OCCURRED IN THIS REPORTED INSTANCE.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: FOREIGN MATERIAL FOUND IN THE TUBING. VISUAL INSPECTION OF THE TUBING PRIOR TO USE PREVENTED THE TUBING FROM BEING USED FOR A PATIENT PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35345 STELLANT SYRINGE KIT ANGIOGRAPHIC SYRINGE KIT DXT MEDRAD 3010860 122919

    Patients

    Seq Age Sex Outcome Treatment
    1 STELLANT ANGIOGRAPHIC INJECTOR