BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW RA CATH SET: 22 GA X 1-3/8"

    MDR report key: 8306209 · Received February 5, 2019

    Report

    Report Number
    9680794-2019-00034
    Event Type
    Malfunction
    Date Received
    February 5, 2019
    Date of Event
    January 3, 2019
    Report Date
    January 23, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQX
    PMA / PMN Number
    K810675
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    COMPLAINT DESCRIPTION: "3 MONTHS OLD GIRL IS TAKEN TO SURGERY FOR AORTIC ARCH CORRECTION SURGERY, SHE CANALIZED ARTERIAL ARROW CATHETER RIGHT BRACHIAL ON (B)(6) 2019. ON THE NIGHT SHIFT, BLEEDING IS OBSERVED AT THE INSERTION SITE, WHEN THE CATHETER IS CHECKED, A BROKEN CATHETER IS SEEN WITH THE MOVEMENT OF THE BABY, THE CATHETER IS BENT, FRACTURED AND BROKEN".

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION REQUESTED REGARDING THIS EVENT. NO ADDITIONAL INFORMATION RECEIVED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    COMPLAINT DESCRIPTION: "(B)(6) OLD GIRL IS TAKEN TO SURGERY FOR AORTIC ARCH CORRECTION SURGERY, SHE CANALIZED ARTERIAL ARROW CATHETER RIGHT BRACHIAL ON (B)(6) 2019. ON THE NIGHT SHIFT, BLEEDING IS OBSERVED AT THE INSERTION SITE, WHEN THE CATHETER IS CHECKED, A BROKEN CATHETER IS SEEN WITH THE MOVEMENT OF THE BABY, THE CATHETER IS BENT, FRACTURED AND BROKEN".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    101180 ARROW RA CATH SET: 22 GA X 1-3/8" WIRE GUIDE CATHETER DQX ARROW INTERNATIONAL INC. 14F17G0322

    Patients

    Seq Age Sex Outcome Treatment
    1 3 MO