BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 3-LUMEN 7 FR X 20 CM

    MDR report key: 9745135 · Received February 24, 2020

    Report

    Report Number
    3006425876-2020-00162
    Event Type
    Malfunction
    Date Received
    February 24, 2020
    Date of Event
    January 23, 2020
    Report Date
    February 5, 2020
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER RETURNED ONE CVC 3-L CATHETER FOR EVALUATION. VISUAL INSPECTION REVEALED THE DISTAL EXTENSION LINE HAD BECOME SEPARATED JUST ADJACENT TO THE LUER HUB. REMAINS OF THE EXTENSION LINE WERE FOUND INSIDE THE LUER HUB. THE POINTS OF SEPARATION WERE ROUGH AND JAGGED, CONSISTENT WITH UNDUE FORCE BEING APPLIED TO THE EXTENSION LINE. THE LENGTH OF THE CATHETER BODY MEASURED 216MM WHICH IS WITHIN SPECIFICATIONS OF 207-227MM PER CATHETER PRODUCT DRAWING. THE OUTER DIAMETER OF THE DISTAL EXTENSION LINE MEASURED 2.173MM WHICH IS WITHIN SPECIFICATIONS OF 2.13-2.21MM PER DISTAL EXTENSION LINE EXTRUSION GRAPHIC. THE INNER DIAMETER OF THE DISTAL EXTENSION LINE MEASURED 1.4224MM WHICH IS WITHIN SPECIFICATIONS OF 1.42-1.50MM PER DISTAL EXTENSION LINE EXTRUSION GRAPHIC EBZ-80854-002 REV. 01. A MANUAL TUG TEST CONFIRMED THE PROXIMAL AND MEDIAL LUER HUBS WERE FULLY SECURE TO THEIR EXTENSION LINES. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THIS KIT WARNS THE USER, "OPEN SLIDE CLAMP PRIOR TO INFUSION THROUGH LUMEN TO REDUCE RISK OF DAMAGE TO EXTENSION LINE FROM EXCESSIVE PRESSURE." THE REPORT OF AN EXTENSION LINE/LUER HUB SEPARATION WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL ANALYSIS REVEALED THAT THE DISTAL EXTENSION LINE HAD SEPARATED ADJACENT TO THE LUER HUB. IT WAS NOTED THAT REMAINS OF THE EXTENSION LINE WERE FOUND WITHIN THE LUER HUB. THE SEPARATION POINTS WERE JAGGED, INDICATED UNDUE FORCE. THE EXTENSION LINE MET ALL RELEVANT DIMENSIONAL REQUIREMENTS AND A DEVICE HISTORY RECORD REVIEW DID NOT REVEAL ANY RELEVANT FINDINGS. BASED ON THE CUSTOMER REPORT AND THE SAMPLE RECEIVED, UNINTENTIONAL USE 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

    THE CUSTOMER REPORTS THAT THE LUER-LOCK CONNECTION (BROWN HEAD) IS BROKEN DURING USE.

    Additional Manufacturer Narrative · 1

    QN#: (B)(4). PRELIMINARY EVALUATION OF THE RETURNED DEVICE INDICATES EXTENSION LINE/LUE HUB SEPARATION IN USE.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS THAT THE LUER-LOCK CONNECTION (BROWN HEAD) IS BROKEN DURING USE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211199 ARROW CVC SET: 3-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL INC. 71F19D1766

    Patients

    Seq Age Sex Outcome Treatment
    1