BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW CVC SET: 3-LUMEN

    MDR report key: 14798930 · Received June 24, 2022

    Report

    Report Number
    9680794-2022-00389
    Event Type
    Injury
    Date Received
    June 24, 2022
    Date of Event
    April 28, 2022
    Report Date
    June 3, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). MEDWATCH REPORT# MW5109672.

    Additional Manufacturer Narrative · 0

    (B)(4). MEDWATCH REPORT# MW5109672. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER; THEREFORE, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED UPON A LOT NUMBER FROM THE SALES HISTORY DATA OF THE CUSTOMER. 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

    MEDWATCH FORM RECEIVED REPORTS: "PROVIDER ATTEMPTED TO PLACE A R SIDED IJ LINE; FOLLOWING ONE OF THE ATTEMPTS, THE GUIDEWIRE APPEARED FRAYED AND WAS REMOVED. CT SHOWED LINEAR DENSITY IN THE R INTERNAL JUGULAR VEIN SUSPICIOUS FOR RETAINED CENTRAL VENOUS CATHETER OR NEEDLE COMPONENTS." ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    MEDWATCH FORM RECEIVED REPORTS: "PROVIDER ATTEMPTED TO PLACE A R SIDED IJ LINE; FOLLOWING ONE OF THE ATTEMPTS, THE GUIDEWIRE APPEARED FRAYED AND WAS REMOVED. CT SHOWED LINEAR DENSITY IN THE R INTERNAL JUGULAR VEIN SUSPICIOUS FOR RETAINED CENTRAL VENOUS CATHETER OR NEEDLE COMPONENTS." ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    307432 ARROW CVC SET: 3-LUMEN CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other