BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CVC SET: 14 GA X 20 CM

    MDR report key: 1911045 · Received November 24, 2010

    Report

    Report Number
    9680794-2010-00075
    Event Type
    Injury
    Date Received
    November 24, 2010
    Date of Event
    October 8, 2010
    Report Date
    November 24, 2010
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DQY
    PMA / PMN Number
    K820009
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    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 AFTER THE NEEDLE WAS INSERTED VIA THE RIGHT SUBCLAVIAN VEIN, THE METAL PORTION DISCONNECTED FROM THE PLASTIC "CONNECTOR" OR HUB. THE METAL PORTION OF THE NEEDLE BECAME "STUCK" IN THE PTS' BODY. AS A RESULT, A SURGICAL PROCEDURE WAS NECESSARY TO EXTRACT THE NEEDLE FROM THE PATIENT'S BODY. THE NEEDLE WAS REMOVED FROM THE PT'S BODY IN ANOTHER HOSPITAL FACILITY BY A CARDIOVASCULAR SURGEON. THE PATIENT OUTCOME IS UNK AT THIS TIME. ADD'L INFO RECEIVED FROM THE DISTRIBUTOR ON 11/18/2010 STATED THAT "CENTRAL VENOUS CATHETERIZATION SET WAS ESTABLISHED FOR THE SUBCLAVIAN VEIN. NEEDLE "FLOWED" ON, HAMMERED IN A SHALLOW DISH IN THE VICINITY OF THE TRACHEA. THE PT WAS GOOD, EVERYTHING WAS FINE. THE WOMAN WAS TRANSPORTED TO THE VASCULAR DEPARTMENT AT ANOTHER HOSPITAL IN ORDER TO REMOVE THE NEEDLE FROM THE VESSEL. THE NEEDLE WAS REMOVED BY SURGERY UNDER GENERAL ANESTHESIA. AFTER THAT SHE RETURNED TO THE DEPARTMENT OF NEUROLOGY IN THE SAME DAY. THIS DOES NOT HURT THE HEALTH OF THE PATIENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CVC SET: 14 GA X 20 CM SINGLE LUMEN CVC PRODUCTS DQY ARROW INTERNATIONAL, INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention