BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    XODUS MEDICAL

    MDR report key: 10174760 · Received June 19, 2020

    Report

    Report Number
    3014527682-2020-00006
    Event Type
    Malfunction
    Date Received
    June 19, 2020
    Date of Event
    June 4, 2020
    Report Date
    June 12, 2020
    Manufacturer
    XODUS MEDICAL
    Product Code
    LYV
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 1

    USER NOTICED THAT THE CUSTOM LABELS IN THE ANGIO-SPECIAL PROCEDURE PACK FLAKE OFF WHEN THE SYRINGES ARE LEFT IN A SALINE BOWL. THIS DOES NOT HAPPEN VERY OFTEN IN THE CATH LAB, BUT THERE IS A POSSIBILITY THAT A TECH COULD LEAVE A SYRINGE IN THE WIRE BOWL AND THIS WOULD HAPPEN. WE SAW THIS IN THE OR WHEN WE ARE WORKING ON AN EVAR PROCEDURE. THE SURGERY TECHS LEAVE THE SYRINGES IN THE FLUSH BOWL UNTIL THE MD NEEDS ONE. IN DOING THIS THE LABELS FLAKE APART. WE HAVE HAD TO DISCARD FLUID OFF OF THE SCRUB TABLE IN TWO PROCEDURES NOW. WE NOW REALIZE WHAT IS CAUSING THE PROBLEM AND HAVE DISCUSSED WITH THE SURGERY TECHS TO NOT USE THE LABELS THAT ARE PROVIDED IN THE ANGIO-SPECIAL PROCEDURE PACKS. THIS IS AN INCONVENIENCE, BUT I AM MORE CONCERNED WITH THE POSSIBILITY OF THIS HAPPENING DURING OTHER PROCEDURES AND THESE PARTICLES GETTING INJECTED INTO A PATIENT'S ARTERY. CUSTOM LABEL NSCL23635, LOTS: 200203, 170913, 170703 FROM XODUS MEDICAL WERE PLACED INSIDE ROI CPS, LLC ANGIO SPECIAL PROCEDURE CUSTOM PACK 800701002 (HT00906B), LOT: 77188B.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    636255 XODUS MEDICAL CUSTOM LABEL NSCL23635 LYV XODUS MEDICAL NSCL23635 200203, 170913, 17070

    Patients

    Seq Age Sex Outcome Treatment
    1