BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROWG+ARD CATHETER PRODUCTS

    MDR report key: 1201490 · Received October 17, 2008

    Report

    Report Number
    1036844-2008-00205
    Event Type
    Injury
    Date Received
    October 17, 2008
    Date of Event
    October 8, 2008
    Report Date
    October 14, 2008
    Manufacturer
    ARROW INTL INC
    Product Code
    DQO
    PMA / PMN Number
    K993691
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SAMPLE WILL NOT BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE CLINICIAN THAT THE PROCEDURE WAS BEING PERFORMED ON A FEMALE PT. A TRIPLE LUMEN CATHETER WAS BEING PLACED IN THE SUBCLAVIAN VEIN WHEN THE SPRING WIRE GUIDE (SWG) BEGAN TO UNCOIL AND SEPARATE. AN X-RAY WAS PERFORMED AND A "SMALL PIECE" OF THE SWG WAS RETAINED IN THE PT'S SOFT TISSUE. A CONSULT IS BEING DONE BY THE HOSP TO DETERMINE IF THEY WILL LEAVE THE PIECE IN THE PT OR REMOVE IT. THERE HAVE BEEN NO PT COMPLICATIONS REPORTED. IN 2008, SALES REP STATED THAT THEY WILL BE LEAVING THE WIRE SEGMENT IN THE PT. THE NURSING DIR WILL BE MEETING WITH THE MEDICAL DIR TO DISCUSS ADDITIONAL IN-SERVICING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARROWG+ARD CATHETER PRODUCTS DQO ARROW INTL INC UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK