BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LUMEN/PSI KIT

    MDR report key: 2852613 · Received November 14, 2012

    Report

    Report Number
    1036844-2012-00321
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 31, 2012
    Report Date
    November 13, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DYB
    PMA / PMN Number
    K002507
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROCEDURE WAS BEING PERFORMED IN THE OPERATING ROOM. THE SHEATH WAS PLACED INTO THE PATIENT'S INTERNAL JUGULAR. THE PHYSICIAN THEN INSERTED THE THERMODILUTION CATHETER. AFTER INSERTION, HE REALIZED THE HEMOSTASIS VALVE WAS LEAKING AROUND THE CATHETER. THE CATHETER WAS KEPT IN PLACE AND USED SUCCESSFULLY. THEY WERE USING A 7FR EDWARDS SWAN GANZ CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MULTI-LUMEN/PSI KIT MULTI-LUMEN ACCESS CATHETERS DYB ARROW INTL., INC. RF2057115

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 7FR EDWARDS SWAN GANZ CATHETER