BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW MULTI-LUMEN CVC KIT

    MDR report key: 12099396 · Received June 30, 2021

    Report

    Report Number
    MW5102225
    Event Type
    Injury
    Date Received
    June 30, 2021
    Date of Event
    June 29, 2021
    Report Date
    June 29, 2021
    Manufacturer
    ARROW INTERNATIONAL, LLC
    Product Code
    FOZ
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A RIGHT IJ TRIPLE LUMEN CATHETER WAS INSERTED IN A PT WITH SEVERE SEPSIS. AT THE CONCLUSION OF THE PROCEDURE, IT WAS NOTED THE GUIDEWIRE WAS RETAINED WITHIN THE CATHETER AND PARTIALLY IN THE IVC. THE CATHETER WAS NOT FREE-FLOATING AND WAS SUCCESSFULLY RETRIEVED BY IR. UNFORTUNATELY, GUIDEWIRES HAVE A KNOWN DESIGN "FLOW" IN THAT THERE WAS NO HARD-STOP DESIGN MEASURES, OTHER THAN THE PROFESSIONAL USER, TO PREVENT A GUIDEWIRE FROM 'SLIPPING AWAY' INTO THE CATHETER ITSELF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    989827 ARROW MULTI-LUMEN CVC KIT CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS FOZ ARROW INTERNATIONAL, LLC 23F20K0126

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention