BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARTERIAL CATH SET:20GA C ATH/22GA NDL

    MDR report key: 2033915 · Received February 11, 2011

    Report

    Report Number
    1036844-2011-00051
    Event Type
    Malfunction
    Date Received
    February 11, 2011
    Date of Event
    January 26, 2011
    Report Date
    February 11, 2011
    Manufacturer
    ARROW INTL., INC.
    Product Code
    DQX
    PMA / PMN Number
    K810675
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    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

    REFERENCE MDR #1036844-2011-00050 FOR THE FIRST EVENT INVOLVING THE SAME PT. IT WAS REPORTED THAT THE CATHETER WAS PLACED IN THE PT'S RIGHT BRACHIAL ARTERY. POST INSERTION, BLEEDING WAS NOTICED AT THE INSERTION SITE AND THE DRESSING WAS REMOVED. THEY DISCOVERED A CRACK IN THE CATHETER PORT OF THE LINE. AS A RESULT, IT WAS REMOVED WITHOUT INCIDENT AND WAS DISCONTINUED. THERE WAS NO DELAY IN TREATMENT, NO PT DEATH AND NO PT COMPLICATIONS WERE REPORTED. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ARTERIAL CATH SET:20GA C ATH/22GA NDL ARTERIAL CATHETER PRODUCTS DQX ARROW INTL., INC. NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK