BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3843704 · Received March 25, 2014

    Report

    Report Number
    9680794-2014-00077
    Event Type
    Malfunction
    Date Received
    March 25, 2014
    Date of Event
    March 16, 2014
    Report Date
    March 18, 2014
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K810675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN ARTERIAL LINE WAS INSERTED INTO THE (B)(6) FEMALE PATIENT'S RIGHT RADIAL ARTERY ON (B)(6). (B)(6), THE USER WAS UNABLE TO PICK UP WAVEFORM READINGS AND WAS UNABLE TO PERFORM A BLOOD DRAW. THE USER REPORTED THAT THEY REPEATEDLY FLUSHED THE LINE, BUT IT WAS STILL NOT ABLE TO WORK. AS A RESULT, THE DEVICE WAS REMOVED AND A NEW RADIAL CATHETER WAS PLACED INTO THE PATIENT'S LEFT RADIAL ARTERY TO SUCCESSFULLY PERFORM THE PROCEDURE. THERE WAS NO DELAY, DEATH, COMPLICATION, OR HARM TO THE PATIENT AS A RESULT OF THIS OCCURRENCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173795 RA CATH SET: 20GA X 1-1/2 ARTERIAL CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 40 YR