BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 14 GA X 8" (20 CM)

    MDR report key: 10303120 · Received July 21, 2020

    Report

    Report Number
    3006425876-2020-00643
    Event Type
    Malfunction
    Date Received
    July 21, 2020
    Date of Event
    May 19, 2020
    Report Date
    July 15, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER RETURNED AN INTRODUCER NEEDLE AND A LIDSTOCK FOR ANALYSIS. SIGNS-OF-USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED. VISUAL ANALYSIS REVEALED THAT THE CANNULA OF THE INTRODUCER NEEDLE CONTAINED TWO DENTS AND ONE SCRATCH MARK ACROSS THE EXTRUSION. MICROSCOPIC EXAMINATION CONFIRMED THE DENTS. THE APPEARANCE OF THE DENTS IS CONSISTENT WITH THE DEVICE BECOMING CRUSHED. THE DENTS IN THE CANNULA MEASURED 36MM, 45MM, AND 47MM FROM THE CANNULA HUB. THE CANNULA LENGTH ACCORDING TO MEASUREMENT A IN THE INTRODUCER NEEDLE GRAPHIC MEASURED 68.5MM, WHICH IS WITHIN THE SPECIFICATION LIMITS OF 67.13MM-68.91MM. THE CANNULA INNER DIAMETER AT THE PROXIMAL END MEASURED .041", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .041"-.043" PER THE CANNULA GRAPHIC. THE CANNULA OUTER DIAMETER (IN AN AREA THAT WAS NOT DAMAGED) MEASURED .050", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .050"-.051" PER THE CANNULA GRAPHIC. THIS INDICATES THE WALL THICKNESS OF THE CANNULA IS WITHIN SPECIFICATIONS. A LAB INVENTORY GUIDE WIRE WITH THE SAME DIAMETER AS THE ONE PACKAGED WITHIN THIS KIT WAS INSERTED THROUGH THE CANNULA. MAJOR RESISTANCE WAS OBSERVED WHEN THE GUIDE WIRE REACHED THE DENTS, WHICH PREVENTED THE GUIDE WIRE FROM PASSING. MANUFACTURING ENGINEERING WAS CONTACTED AS PART OF THIS COMPLAINT INVESTIGATION. THEY STATED THAT THE INTRODUCER NEEDLES ARE 100% INSPECTED FOR DENTS AND SCRATCH MARKS. THEY ALSO INDICATED THAT IT IS MORE LIKELY THAT THIS DAMAGE WAS CREATED BY NEEDLE HOLDERS DURING USE ON THE PATIENT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE REPORT OF A DENTED NEEDLE CANNULA WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL AND FUNCTIONAL ANALYSIS REVEALED THREE DENTS ON THE NEEDLE CANNULA. THE APPEARANCE OF THE DEFECT APPEARS CONSISTENT WITH DAMAGE DUE TO CRUSHING FORCE. PRODUCT ENGINEERING WAS CONSULTED AND THEY INDICATED THAT THE DEFECT HAS THE APPEARANCE OF DAMAGE RESULTING FROM NEEDLE HOLDERS BEING USED ON THE NEEDLE DURING USE. THE NEEDLE CANNULA MET ALL RELEVANT DIMENSIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS IDENTIFIED. BASED ON THE CUSTOMER REPORT AND ENGINEERING FEEDBACK, UNINTENTIONAL USER ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE INTRODUCER NEEDLE HAD NOT BEEN CHECKED BEFORE THE PUNCTURE, BUT AFTER IT WAS FIXED AND IT WAS NOTED THAT THE GUIDE WIRE COULD NOT BE INSERTED. AFTER SEVERAL INSERTION ATTEMPTS, THE INTRODUCER NEEDLE WAS PULLED OUT FOR EXAMINATION. ONLY THEN IT WAS FOUND WITH OBVIOUS INDENTATION ON THE SIDE OF THE INTRODUCER NEEDLE.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE INTRODUCER NEEDLE HAD NOT BEEN CHECKED BEFORE THE PUNCTURE, BUT AFTER IT WAS FIXED AND IT WAS NOTED THAT THE GUIDE WIRE COULD NOT BE INSERTED. AFTER SEVERAL INSERTION ATTEMPTS, THE INTRODUCER NEEDLE WAS PULLED OUT FOR EXAMINATION. ONLY THEN IT WAS FOUND WITH OBVIOUS INDENTATION ON THE SIDE OF THE INTRODUCER NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    769792 ARROW CVC SET: 14 GA X 8" (20 CM) CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL INC. 71F17J0694

    Patients

    Seq Age Sex Outcome Treatment
    1