BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RA CATH SET: 20 GA X 2-1 /2

    MDR report key: 2801097 · Received October 17, 2012

    Report

    Report Number
    1036844-2012-00290
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    September 21, 2012
    Report Date
    October 15, 2012
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQX
    PMA / PMN Number
    K810675
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). SAMPLE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PROCEDURE WAS BEING PERFORMED ON A MALE PT WEIGHING (B)(6) IN THE INTENSIVE CARE UNIT. THE PT HAD A HISTORY OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE, HYPERTENSION ARTERIAL SYSTEMIC AND CHAGAS DISEASE. THE PT WAS ADMITTED FOR LUMPECTOMY, LUNG BIOPSY, PLEURECTOMY AND THORACOSTOMY. THE CATHETER WAS PLACED INTO THE PT'S RIGHT RADIAL ARTERY. ACCORDING TO THE NURSE RESPONSIBLE FOR THE ROOM AT THE TIME OF THE PROCEDURE, THE CATHETER HAD A HOLE IN THE FASTENER AT THE JUNCTION AND THERE WAS ABUNDANT BLEEDING AT THE INSERTION SITE. THERE WAS NO DELAY IN TREATMENT AND NO PT DEATH OR COMPLICATIONS WERE REPORTED. THE PT IS DOING WELL AND IS IN THE INFIRMARY. F/U INFO RECEIVED ON (B)(6) 2012 STATES THERE WAS A HOLE IN THE JUNCTURE HUB. THE BLOOD LEAKING WAS ONLY AT THE INSERTION SITE AND NO BLOOD TRANSFUSION WAS REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RA CATH SET: 20 GA X 2-1 /2 ARTERIAL CATHETER PRODUCTS DQX ARROW INTL., INC. RF1057099

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK