BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NA

    MDR report key: 3202049 · Received June 27, 2013

    Report

    Report Number
    3006425876-2013-00118
    Event Type
    Malfunction
    Date Received
    June 27, 2013
    Date of Event
    June 2, 2013
    Report Date
    June 26, 2013
    Manufacturer
    ARROW INTERNATIONAL INC
    Product Code
    DQY
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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 WHILE IN THE M21 DEPARTMENT OF THE HOSPITAL, AFTER 46 DAYS OF USAGE THE BROWN LUMEN IS LEAKY. LIQUID RAN ACROSS THE CHEST OF THE PT. THE CATHETER IS A 4 LUMEN 8.5FR CATHETER IMPREGNATED ARROWGARD AND WAS INSERTED INTO THE VENA JUGULARIS INTERNAL. THE CATHETER WAS REMOVED AND NEW ONE WAS INSERTED. THERE WAS A DELAY IN TREATMENT, BUT NO HARM WAS CAUSED TO THE PT. NO COMPLICATIONS OR DEATH OCCURRED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293193 NA ARROWG+ARD CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK