BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3820512 · Received April 11, 2014

    Report

    Report Number
    9680794-2014-00086
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    April 7, 2014
    Report Date
    April 8, 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 ON (B)(6) 2014, THE CATHETER WAS INSERTED INTO THE PATIENT'S RIGHT RADIAL ARTERY IN THE CCTC. ON (B)(6) 2014, THE PATIENT PRESENTED WITH A DAMPENED WAVEFORM AND THEY COULD NOT DRAW BLOOD. AS A RESULT, THE CATHETER WAS REMOVED AND REPLACED FOR THE PATIENT. THERE WAS NO DELAY IN TREATMENT AND NO PATIENT DEATH OR COMPLICATIONS REPORTED. IT WAS NOTED THE CATHETER BODY WAS KINKED WHEN REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221195 RA CATH SET: 20 GA X 1-1/2 ARTERIAL CATHETER PRODUCTS DQY ARROW INTERNATIONAL INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1