BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 3-LUMEN 12 FR X 16 CM

    MDR report key: 10158367 · Received June 16, 2020

    Report

    Report Number
    3006425876-2020-00527
    Event Type
    Malfunction
    Date Received
    June 16, 2020
    Date of Event
    April 26, 2020
    Report Date
    June 5, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. 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 (LOT#71F20C2816). 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

    IT WAS REPORTED THAT THE CENTRAL LINE AND VASCATH BOTH INSERTED INTO LEFT JUGULAR VEIN (LIJ) ON (B)(6) 2020. DIFFICULTY USING THE VASCATH NOTED ON (B)(6) 2020 WITH CONTINUOUS ALARMS OF HIGH PRESSURES AND UNABLE TO ASPIRATE ON ONE OF THE PORTS. DECISION TO INSERT NEW VASCATH INTO RIGHT INTERNAL JUGULAR (RIJ). ON CHECKING THE CXR FOLLOWING THE NEW RIJ LINE INSERTION, AN OPACITY WAS NOTED DISTAL TO THE OLD LIJ VASCATH. ON REMOVING THE OLD LIJ VASCATH THE USER CUT THE DISTAL END OF THE VASCATH, TO DISCOVER ONE PORT WAS FILLED WITH WHITE PLASTIC LOOKING MATERIAL. DELAY IN TREATMENT TO DUE NEW INSERTION OF CVC.

    Additional Manufacturer Narrative · 1

    QN# (B)(4). IT IS UNKNOWN IF THE DEVICE SAMPLE IS AVAILABLE FOR EVALUATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CENTRAL LINE AND VASCATH BOTH INSERTED INTO LEFT JUGULAR VEIN (LIJ) ON (B)(6) 2020. DIFFICULTY USING THE VASCATH NOTED ON (B)(6) 2020 WITH CONTINUOUS ALARMS OF HIGH PRESSURES AND UNABLE TO ASPIRATE ON ONE OF THE PORTS. DECISION TO INSERT NEW VASCATH INTO RIGHT INTERNAL JUGULAR (RIJ). ON CHECKING THE CXR FOLLOWING THE NEW RIJ LINE INSERTION, AN OPACITY WAS NOTED DISTAL TO THE OLD LIJ VASCATH. ON REMOVING THE OLD LIJ VASCATH THE USER CUT THE DISTAL END OF THE VASCATH, TO DISCOVER ONE PORT WAS FILLED WITH WHITE PLASTIC LOOKING MATERIAL. DELAY IN TREATMENT TO DUE NEW INSERTION OF CVC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    621005 ARROW CVC SET: 3-LUMEN 12 FR X 16 CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL INC. IPN038301 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1