BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DIALYSIS CATHETER

    MDR report key: 673714 · Received February 7, 2006

    Report

    Report Number
    1720496-2006-00055
    Event Type
    Injury
    Date Received
    February 7, 2006
    Report Date
    January 13, 2006
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LFJ
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AFTER SPEAKING WITH THE DIRECTOR OF SURGICAL SERVICES AT ST JOSEPH HOSPITAL. THEY STATED "IT WAS AN ASHSPLIT NOT A HEMOSPLIT." ASHSPLIT IS NOT A BARD ACCESS SYSTEMS PRODUCT.

    Description of Event or Problem · 1

    WHILE DR WAS ATTEMPTING TO DO AN ASH CATH INSERTION, A PART OF THE CATHETER BECAME STUCK IN THE PATIENT'S LEFT SUBCLAVIAN AND SUPERIOR VENA CAVA. ANOTHER SURGEON WAS CALLED STAT, THE CATH LAB STAFF CALLED IN AND INVOLVED IN REMOVING THE CATHETER. THE PRODUCT CATHETER WAS INSPECTED TO ENSURE IT WAS COMPLETELY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIALYSIS CATHETER BLOOD ACCESS DEVICE AND ACCESSORIES LFJ C.R. BARD, INC. (BASD) * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 *