BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BROV 4.2 FR W/VITA

    MDR report key: 823060 · Received February 5, 2007

    Report

    Report Number
    1720496-2007-00049
    Event Type
    Injury
    Date Received
    February 5, 2007
    Date of Event
    February 3, 2007
    Report Date
    February 5, 2007
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A BREAK WAS CONFIRMED AND APPEARS TO BE USER RELATED. THE 2.7 FR TUBING BROKE APPROXIMATELY 0.5 INCHES DISTAL TO THE STRENGTHENING SHEATH. THE CATHETER WAS APPARENTLY BURST FROM OVERPRESSURIZATION. THE LUMEN OF THE 2.7 FR TUBING WAS OCCLUDED WITH BLOOD RESIDUE DISTAL TO THE BREAK. A LONGITUDINAL SPLIT CONTINUED DISTALLY FROM THE BREAK SITE. THE PRODUCT IFU NOTES THAT, WHILE SMALLER LUMEN BROVIAC CATHETERS HAVE BEEN USED SUCCESSFULLY FOR BLOOD WITHDRAWAL, THEIR SMALL LUMEN SIZES INCREASE THE CHANCE OF CLOTTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER FRACTURED A FEW CM ABOVE THE HUB. IT EMBOLIZED IN THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BROV 4.2 FR W/VITA IMPLANTED LONG TERM INTRAVASCULAR DQO C.R. BARD, INC. (BASD) * REQ0252

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention