BEUDAMED
    FDA Adverse Event Death Summary report: N

    GLIDEPATH DIALYSIS CATHETER

    MDR report key: 8595656 · Received May 9, 2019

    Report

    Report Number
    MW5086480
    Event Type
    Death
    Date Received
    May 9, 2019
    Date of Event
    May 1, 2019
    Report Date
    May 7, 2019
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    MSD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    BLED OUT FROM RED PORT OF HER GLIDEPATH DIALYSIS CATHETER THAT WAS IN HER RIGHT FEMORAL VEIN. SHE WAS AT HOME AT THE TIME. THE END CAPS WERE NOT ON THE DIALYSIS PORTS. SOMEHOW THE CLAMP ON THE RED (RETURN) PORT BECAME UNFASTENED. THE CLIP DID LOCK IN THE CLOSED POSITION WHEN TESTED AT OUR OFFICE. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389017 GLIDEPATH DIALYSIS CATHETER CATHETER, HEMODIALYSIS, IMPLANTED MSD BARD ACCESS SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Death