BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 4-LUMEN 8.5FR X 20CM

    MDR report key: 1172863 · Received September 19, 2008

    Report

    Report Number
    3006425876-2008-00002
    Event Type
    Malfunction
    Date Received
    September 19, 2008
    Date of Event
    August 16, 2008
    Report Date
    September 19, 2008
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQO
    PMA / PMN Number
    K962577
    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 INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CUSTOMER THAT IN 2008, DURING THE LEFT INTERNAL JUGULAR VEIN INSERTION, THE MD COULD NOT ASCERTAIN THE DEPTH OF THE CATHETER. TWO DAYS LATER, IT WAS NOTED "THAT THERE WAS A FLUSHING BACK THROUGH OTHER PORTS." IT WAS APPARENT THAT THEY WERE FLUSHING SALINE SOLUTION AT A LOW FLOW RATE IN THE MEDIAL LUMEN. IT WAS ALSO NOTED THAT FLUID LEAKED FROM THE DISTAL LUMEN AS WELL. AS A RESULT, THE CATHETER WAS REMOVED FOUR DAYS LATER; THE MD FELT THE PATIENT WAS NOT AT RISK. THERE WERE NO REPORTED PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 4-LUMEN 8.5FR X 20CM ARROWG+ARD CATHETER PRODUCTS DQO ARROW INTERNATIONAL INC. ZF7116018

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR SALINE SOLUTION