BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW PEDIATRIC MULTI-LUMEN CATHETER SET

    MDR report key: 359809 · Received October 31, 2001

    Report

    Report Number
    1036844-2001-00080
    Event Type
    Injury
    Date Received
    October 31, 2001
    Report Date
    October 22, 2001
    Manufacturer
    ARROW INTERNATIONAL, INC.
    Product Code
    DQO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SI
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER WAS INSERTED VIA THE SUBCLAVIAN ROUTE. DURING A 10 HOUR PERIOD OF USE, 200ML OF DS 1/4 RINGERS SOLUTION ACCUMULATED IN THE RIGHT PLEURAL CAVITY. A THORACIC CATHETER WAS PLACED TO THE DRAIN THE FLUID WHICH WAS CAUSING TACHYCARDIA AND DYSPNEA. THE REPORTER ATTRIBUTES THE FLUID ACCUMULATION TO EXTRAVASATION RELATING TO THE EXTRAVASCULAR POSITION OF THE PROXIMAL LUMEN. THERE WERE NO FURTHER COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48731 ARROW PEDIATRIC MULTI-LUMEN CATHETER SET CENTRAL VENOUS CATHETER SET DQO ARROW INTERNATIONAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 3 YR Required Intervention