BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 11124149 · Received January 6, 2021

    Report

    Report Number
    3006425876-2021-00031
    Event Type
    Malfunction
    Date Received
    January 6, 2021
    Date of Event
    December 10, 2020
    Report Date
    December 15, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) THE CUSTOMER RETURNED ONE CATHETER OVER NEEDLE ASSEMBLY. SIGNS-OF-USE IN THE FORM OF BIOLOGICAL MATERIAL WAS OBSERVED INSIDE THE NEEDLE HUB. VISUAL ANALYSIS DID NOT REVEAL ANY DEFECTS OR ANOMALIES TO THE CATHETER NOR THE INTRODUCER NEEDLE. UPON COMPLETING DIMENSIONAL AND FUNCTIONAL TESTING, THE CATHETER HUB WAS CROSS SECTIONED IN ORDER TO VIEW ANY POTENTIAL DAMAGE TO THE INSIDE OF THE HUB. NO DEFECTS OR ANOMALIES WERE OBSERVED. THE CATHETER HUB INNER DIAMETER MEASURED .169", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .168"-.170" PER THE CATHETER OVER NEEDLE GRAPHIC. THE CATHETER BODY TOTAL LENGTH MEASURED 3.5", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 3.468"-3.538" PER THE CATHETER OVER NEEDLE GRAPHIC. THE CATHETER BODY OUTER DIAMETER MEASURED .0545", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .053"-.055" PER THE CATHETER EXTRUSION GRAPHIC. THE CATHETER INNER DIAMETER AT THE PROXIMAL END MEASURED .040", WHICH IS WITHIN THE SPECIFICATION LIMITS OF .039"-.041" PER CATHETER EXTRUSION GRAPHIC. A LAB INVENTORY LUER-LOCK SYRINGE FILLED WITH WATER WAS ATTACHED TO THE RETURNED INTRODUCER CATHETER. WITH THE DISTAL END OCCLUDED, THE CATHETER WAS PRESSURIZED, AND NO LEAKS OR DEFECTS WERE OBSERVED. A SIMILAR TEST WAS CONDUCTED WITH THE COMPLETE CATHETER OVER NEEDLE ASSEMBLY. A LAB INVENTORY ARS WAS ATTACHED TO THE NEEDLE HUB AND PRESSURIZED. NO LEAKS WERE OBSERVED. ARROW INTRODUCER CATHETERS ARE NOT DESIGNED AS INJECTION CATHETERS AS THE INTENDED USE IS FOR GUIDE WIRE INTRODUCTION. THEREFORE, THE MODULE REQUIREMENTS FOR THIS COMPONENT (AMRQ-000089 REV 01) DO NOT INCLUDE A SPECIFIC LEAK RESISTANCE REQUIREMENT. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "ENSURE CATHETER PATENCY PRIOR TO INJECTION. DO NOT USE SYRINGES SMALLER THAN 10 ML (A FLUID FILLED 1 ML SYRINGE CAN EXCEED 300 PSI), TO REDUCE RISK OF INTRALUMINAL LEAKAGE OR CATHETER RUPTURE". THE CUSTOMER REPORT OF A LEAKING CATHETER WAS NOT CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL ANALYSIS DID NOT REVEAL ANY DEFECTS OR ANOMALIES WITH THE INTRODUCER CATHETER NOR THE NEEDLE. THE CATHETER AND NEEDLE MET ALL RELEVANT DIMENSIONAL AND FUNCTIONAL TESTING AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS IDENTIFIED. BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED, NO PROBLEM WAS FOUND WITH THE RETURNED SAMPLE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: "WHEN ASPIRATING BLOOD USING "CATHETER OVER NEEDLE", THE USER FOUND AIR WAS LEAKING FROM THE CATHETER OF "CATHETER OVER NEEDLE."(CV CATHETER HAD YET TO BE INSERTED.)" THE DEVICE WAS REPLACED WITH A NEW ONE, AND LEAKING WAS RESOLVED. NO PATIENT INJURY OR COMPLICATION. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Additional Manufacturer Narrative · 1

    QN#: (B)(4).

    Description of Event or Problem · 1

    THE COMPLAINT IS REPORTED AS: "WHEN ASPIRATING BLOOD USING "CATHETER OVER NEEDLE", THE USER FOUND AIR WAS LEAKING FROM THE CATHETER OF "CATHETER OVER NEEDLE."(CV CATHETER HAD YET TO BE INSERTED.)" THE DEVICE WAS REPLACED WITH A NEW ONE, AND LEAKING WAS RESOLVED. NO PATIENT INJURY OR COMPLICATION. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19675 ARROW CVC KIT: 2-LUMEN 7FR X 20CM CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL INC. 71F20B1524

    Patients

    Seq Age Sex Outcome Treatment
    1