BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 3-LUMEN 12 FR X 25 CM

    MDR report key: 15715702 · Received November 2, 2022

    Report

    Report Number
    3006425876-2022-00992
    Event Type
    Malfunction
    Date Received
    November 2, 2022
    Date of Event
    October 7, 2022
    Report Date
    October 13, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE DILATOR AND PRODUCT LIDSTOCK FOR ANALYSIS. NO OBVIOUS SIGNS OF USE WERE OBSERVED ON THE DILATOR. VISUAL ANALYSIS OF THE DILATOR REVEALED THE TIP WAS FRAYED AND DEFORMED. DAMAGE APPEARS CONSISTENT WITH UNDUE FORCE BEING APPLIED TO THE DILATOR DURING INSERTION. THE DILATOR LENGTH MEASURED 5 1/2", WHICH IS WITHIN THE SPECIFICATIONS OF 5 1/4-5 3/4" PER DILATOR PRODUCT DRAWING. THE DILATOR OUTER DIAMETER MEASURED 0.1590" WHICH IS WITHIN THE SPECIFICATIONS OF 0.156-0.160" PER DILATOR PRODUCT DRAWING. THE DILATOR INNER DIAMETER AT THE PROXIMAL END MEASURED .054" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .051" - .061" PER DILATOR PRODUCT DRAWING. THE INNER DIAMETER OF THE DILATOR AT THE DISTAL TIP COULD NOT BE MEASURED DUE TO THE DAMAGE TO THE TIP. FUNCTIONAL INSPECTION OF THE DILATOR WAS PERFORMED PER THE PRODUCT INSTRUCTIONS FOR USE WHICH STATES, "USE TISSUE DILATOR TO ENLARGE TISSUE TRACT TO THE VEIN AS REQUIRED. FOLLOW THE ANGLE OF THE GUIDEWIRE SLOWLY THROUGH THE SKIN." A LAB INVENTORY GUIDE WIRE THREADED THROUGH THE DILATOR WITH MINIMAL RESISTANCE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE INSTRUCTIONS FOR USE PROVIDED WITH THIS KIT INFORMS THE USER, "DO NOT USE EXCESSIVE FORCE WHEN INTRODUCING GUIDEWIRE OR TISSUE DILATOR AS THIS CAN LEAD TO VESSEL PERFORATION, BLEEDING , OR COMPONENT DAMAGE." THE CUSTOMER REPORT OF A DAMAGED DILATOR TIP WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. VISUAL INSPECTION CONFIRMED THE DILATOR TIP WAS DEFORMED AND FRAYED. THE APPEARANCE OF THIS DAMAGE IS CONSISTENT WITH UNDUE FORCE BEING APPLIED ON THE DILATOR DURING INSERTION. BASED ON THESE CIRCUMSTANCES , UNINTENTIONAL USE ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR COMPLAINTS OF THIS NATURE. CORRECTED DATA: SECTION B.7. "DELAYED INTUBATION WITH RISK OF RESPIRATORY COMPROMISE OF THE PATIENT." WAS REPORTED ON THE INITIAL REPORT SUBMITTED; HOWEVER, THIS HAS BEEN REMOVED AS IT WAS REPORTED BY THE CUSTOMER IN ERROR.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED ON 07OCT2022, THAT INCREASED RESISTANCE WAS NOTICED WITH THE INTRODUCTION OF THE CENTRAL VENOUS CATHETER (CVC), MEANING THAT MORE PRESSURE HAD TO BE APPLIED. WHEN SEARCHING FOR THE CAUSE, IT WAS FOUND THAT THE DILATOR'S TIP WAS FRAYED.

    Description of Event or Problem · 0

    IT WAS REPORTED ON (B)(6) 2022, THAT INCREASED RESISTANCE WAS NOTICED WITH THE INTRODUCTION OF THE CENTRAL VENOUS CATHETER (CVC), MEANING THAT MORE PRESSURE HAD TO BE APPLIED. WHEN SEARCHING FOR THE CAUSE, IT WAS FOUND THAT THE DILATOR'S TIP WAS FRAYED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275696 ARROW CVC SET: 3-LUMEN 12 FR X 25 CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL LLC IPN919642 71F22B0272

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Unknown N/A.| N/A.