BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CVC SET: 5-LUMEN 8.5FR X 20CM

    MDR report key: 1230371 · Received November 7, 2008

    Report

    Report Number
    3006425876-2008-00007
    Event Type
    Malfunction
    Date Received
    November 7, 2008
    Date of Event
    October 13, 2008
    Report Date
    November 7, 2008
    Manufacturer
    ARROW INTL INC
    Product Code
    DQO
    PMA / PMN Number
    K862056
    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 THIS EVENT INVOLVED A RIGHT INTERNAL JUGULAR INSERTION. AFTER INSERTION OF THE CENTRAL VENOUS CATHETER IT WAS NOT NOTED WHICH LINE WAS USED TO ADMINISTER DRUGS. THERE SEEMED TO BE LEAKAGE COMING FROM THE INSERTION SITE AS THE FLUID GATHERED ON THE PATIENT'S NECK. AS A RESULT, THE CATHETER WAS REMOVED FROM THE PATIENT. A NEW CATHETER WAS PLACED IN THE PATIENT USING A NEW LOT NUMBER WITHOUT EVENT. ALSO REPORTED ALL THE LINES INVOLVED WERE ACCURATELY PLACED BY X-RAY. THERE WERE NO REPORT PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 5-LUMEN 8.5FR X 20CM ADULT MULTI-LUMEN CATHETER PRODUCTS DQO ARROW INTL INC ZF7105616

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK