BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRIS SOLARIS SYRINGE KIT

    MDR report key: 4398777 · Received January 5, 2015

    Report

    Report Number
    2520313-2015-00002
    Event Type
    Malfunction
    Date Received
    January 5, 2015
    Date of Event
    October 15, 2014
    Report Date
    December 9, 2014
    Manufacturer
    BAYER MEDICAL CARE, INC.
    Product Code
    DXT
    PMA / PMN Number
    K012950
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) RADIOLOGY PRODUCT ANALYSIS RECEIVED AND EXAMINED THE RETURNED SYRINGE, LOT NUMBER 140318, AND CONFIRMED THE PRESENCE OF A PARTICULATE IN THE FLUID PATH THAT WAS COMPOSED OF A NESTING OF FIBERS. THE PARTICLE WAS DETECTED IN THE BARREL OF THE SYRINGE AND MEASURE 1.5 MM IN LENGTH BY 1.5 MM IN WIDTH. THE COMPOSITION OF THE MATERIAL INDICATED THAT THE PARTICULATE COULD POTENTIALLY FRAGMENT WHILE UNDER PRESSURES TYPICALLY GENERATED DURING AN INJECTION. THEREFORE, DUE TO POSSIBLE FRAGMENTATION, THE POTENTIAL OF INJECTION INTO THE PATIENT EXISTS. OUR INVESTIGATION DETERMINED THAT THE PARTICULATE NOTED IN THE SYRINGE WAS INTRODUCED DURING THE MANUFACTURING PROCESS AND WAS NOT DETECTED UPON RECEIPT OF THE SYRINGE FROM THE SUPPLIER. 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, WHICH IS WHAT OCCURRED IN THIS REPORTED INSTANCE.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: AFTER OPENING THE MR SYRINGE KIT AND ON PREPARATION OF THE SYRINGE INJECTION, A FOREIGN BODY WAS SEEN IN THE BARREL OF THE SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    3323 SPECTRIS SOLARIS SYRINGE KIT ANGIOGRAPHIC SYRINGE KIT DXT BAYER MEDICAL CARE, INC. SSQK 65/115VS 140318

    Patients

    Seq Age Sex Outcome Treatment
    1