BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRIS SOLARIS SYRINGE KIT

    MDR report key: 3131223 · Received May 23, 2013

    Report

    Report Number
    2520313-2013-00027
    Event Type
    Malfunction
    Date Received
    May 23, 2013
    Date of Event
    April 26, 2013
    Report Date
    April 26, 2013
    Manufacturer
    MEDRAD, INC.
    Product Code
    DXT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BAYER R & I QUALITY PRODUCT ANALYSIS REVIEWED SEVERAL PHOTOGRAPHS THAT WERE PROVIDED BY THE SITE AND OBSERVED A DEPICTION OF A FOREIGN BODY IN THE SYRINGE. A CURRENT INVESTIGATION AND ANALYSIS IS BEING CONDUCTED. IN THE EVENT ADD'L INFO IS OBTAINED, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    THE SITE REPORTED THE FOLLOWING: FOREIGN BODY IN SYRINGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    230064 SPECTRIS SOLARIS SYRINGE KIT ANGIOGRAPHIC SYRINGE KIT DXT MEDRAD, INC. SSQK 65/115VS 136275

    Patients

    Seq Age Sex Outcome Treatment
    1