BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 2-LUMEN 7 FR X 20 CM

    MDR report key: 10677239 · Received October 14, 2020

    Report

    Report Number
    3006425876-2020-00874
    Event Type
    Malfunction
    Date Received
    October 14, 2020
    Date of Event
    September 21, 2020
    Report Date
    September 23, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER RETURNED ONE INTRODUCER NEEDLE FOR ANALYSIS. SIGNS-OF-USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED ON THE NEEDLE HUB. VISUAL ANALYSIS REVEALED THAT THE NEEDLE CANNULA HAD SEPARATED DIRECTLY ADJACENT TO THE NEEDLE HUB. A CROSS-SECTION OF THE BROKEN ENDS OF THE CANNULA REVEALED THEY ARE OVAL/D SHAPED INDICATING THAT THE CANNULA WAS BENT DURING INSERTION, WHICH LIKELY LEAD TO THE SEPARATION. MICROSCOPIC EXAMINATION CONFIRMED THE DAMAGE ON THE CANNULA. IN ADDITION TO THE SEPARATION, THE NEEDLE CANNULA WAS SLIGHTLY BEND APPROXIMATELY IN THE MIDDLE OF THE CANNULA. THIS LIKELY CONTRIBUTED TO THE SEPARATION. THE NEEDLE CANNULA SEPARATION MEASURED 13MM FROM THE PROXIMAL END. THE NEEDLE CANNULA CUMULATIVE LENGTH MEASURED 2.77", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 2.732"-2.792" PER THE CANNULA GRAPHIC. THE NEEDLE CANNULA OUTER DIAMETER MEASURED .05", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .0495"-.0505" PER THE CANNULA GRAPHIC. THE NEEDLE CANNULA INNER DIAMETER AT THE PROXIMAL AND DISTAL END MEASURED .042", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .041".043" PER THE CANNULA GRAPHIC. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE CANNULA GRAPHIC WAS REVIEWED AS PART OF THIS COMPLAINT INVESTIGATION. THE CUSTOMER REPORT OF A DAMAGED INTRODUCER NEEDLE WAS CONFIRMED BY COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. THE BEND/BREAK IN THE NEEDLE CANNULA IS CONSISTENT WITH DAMAGE SEEN WHEN THE CANNULA IS BENT AND KINKED, THUS WEAKENING THE MATERIAL. THE SAMPLE PASSED ALL RELEVANT DIMENSIONAL TESTING. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. BASED ON THE SAMPLE RECEIVED, UNINTENTIONAL USER ERROR CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED "THE NEEDLE BROKE DURING CATHETER INSERTION WHEN THE NEEDLE WAS OUTSIDE THE PATIENT'S BODY." THE NEEDLE WAS REPLACED AND THE PROCEDURE COMPLETED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED "THE NEEDLE BROKE DURING CATHETER INSERTION WHEN THE NEEDLE WAS OUTSIDE THE PATIENT'S BODY." THE NEEDLE WAS REPLACED AND THE PROCEDURE COMPLETED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141609 ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL INC. IPN038329 71F20F2268

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED.| NONE REPORTED.| NONE REPORTED.