BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MULTI-LUMEN/PSI KIT

    MDR report key: 1963639 · Received December 21, 2010

    Report

    Report Number
    1036844-2010-00375
    Event Type
    Malfunction
    Date Received
    December 21, 2010
    Date of Event
    December 8, 2010
    Report Date
    December 21, 2010
    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). F/U REPORT WILL BE FILED IF ADD'L INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE MDR INSERTED THE MULTI-LUMEN ACCESS CATHETER (MAC) INTO THE RIGHT INTERNAL JUGULAR VEIN. WHEN HE INSERTED THE EDWARDS SWAN-GANZ CATHETER INTO THE HEMOSTASIS VALVE, HE NOTICED A SMALL AMOUNT OF BLOOD LEAKING BACK UP. HE TIED A SUTURE AROUND THE OUTSIDE OF THE PROTECTIVE SHEATH COVERING THE SWAN-GANZ WHICH LIMITED THE LEAKAGE. HE FELT THERE WASN'T A TIGHT ENOUGH FIT BETWEEN THE TWO COMPONENTS. THE PROCEDURE WAS COMPLETED WITH NO OTHER UNUSUAL ISSUES. THE PATIENT WAS SENT TO THE CARDIAC SURGICAL INTENSIVE CARE UNIT (CSICU) AS NORMAL AND THE CATHETER WAS REMOVED THE NEXT DAY WITHOUT INCIDENT. THE PATIENT OUTCOME IS "NORMAL." IT WAS NOTED THAT THE MD HAS NOT EXPERIENCED THIS EVENT BEFORE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK EDWARDS SWAN-GANZ CATHETER