BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8"

    MDR report key: 9099439 · Received September 20, 2019

    Report

    Report Number
    9680794-2019-00353
    Event Type
    Malfunction
    Date Received
    September 20, 2019
    Date of Event
    June 1, 2019
    Report Date
    September 9, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (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. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    MEDWATCH REPORT (B)(4) RECEIVED ON 09/09/2019 INDICATES THAT THE "TIP OF THE CATHETER IS GETTING STRIPPED. POTENTIAL FOR VASCULAR DAMAGE." ORIGINAL INTENDED PROCEDURE: CENTRAL VENOUS CATHETER PLACEMENT.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    MEDWATCH REPORT (B)(4) RECEIVED 09/09/2019 INDICATES THAT THE "TIP OF THE CATHETER IS GETTING STRIPPED. POTENTIAL FOR VASCULAR DAMAGE." ORIGINAL INTENDED PROCEDURE: CENTRAL VENOUS CATHETER PLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    890883 ARROW MULTI-LUMEN PI CVC KIT: 4-L 8.5 FR X 8" CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL INC. 13F19C0497

    Patients

    Seq Age Sex Outcome Treatment
    1