BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK RADIAL ARTERY CATHETER

    MDR report key: 3843690 · Received March 25, 2014

    Report

    Report Number
    1036844-2014-00139
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    March 13, 2014
    Report Date
    March 14, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WILL NOT BE RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED THIS RADIAL ARTERIAL CATHETER WAS BEING USED IN A PATIENT. DURING REMOVAL OF THE CATHETER THEY FOUND A PIECE WAS MISSING. NO X-RAYS WERE TAKEN, AND THE PIECE WAS LEFT IN THE PATIENT. THERE WAS NO DELAY IN TREATMENT AND NO PATIENT DEATH OR COMPLICATIONS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    174157 UNK RADIAL ARTERY CATHETER ARTERIAL CATHETER DQY ARROW INTERNATIONAL INC.

    Patients

    Seq Age Sex Outcome Treatment
    1