BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PSI KIT: 8.5 FR

    MDR report key: 1133071 · Received August 22, 2008

    Report

    Report Number
    2518433-2008-00020
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 29, 2008
    Report Date
    August 22, 2008
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DYB
    PMA / PMN Number
    K781846
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    FOLLOW-UP REPORT WILL BE FILED IF ADDITIONAL INFO BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AS SOON AS THE INTRODUCER WAS INSERTED, AND THE SWAN GANZ IN SITU, IT WAS NOTED THE HEMOSTASIS VALVE WAS FOUND LEAKING AROUND THE CATHETER INTO THE CATHGUARD. AS A RESULT, IT WAS REMOVED AND REPLACED WITHOUT DIFFICULTY OR COMPLICATIONS TO THE PT. THE CLINICIAN REPORTED, "THIS IS THE SECOND TIME THIS HAPPENED. LAST WEEK IT WAS NOTED ON A PT WHOSE CATHETER HAD BEEN INSERTED THREE DAYS EARLIER. THAT ONE WAS ALSO REPLACED BY THE CLINICIAN. THE LOT NUMBER OF THAT CATHETER WAS NOT AVAILABLE. ADDITIONAL INFO RECEIVED INDICATES THAT THE CENTRAL VENOUS CATHETER SET, CV-22854, WAS BEING USED WITH THE CA-09801-SB.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PSI KIT: 8.5 FR CRITICAL CARE PSI PRODUCTS DYB ARROW INTL., INC. ZF8016943

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR