BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM

    MDR report key: 12944153 · Received December 6, 2021

    Report

    Report Number
    3006425876-2021-01099
    Event Type
    Malfunction
    Date Received
    December 6, 2021
    Date of Event
    November 12, 2021
    Report Date
    November 15, 2021
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN#(B)(4). THE CUSTOMER RETURNED ONE 4-L CVC FOR INVESTIGATION. VISUAL INSPECTION REVEALED THE DISTAL EXTENSION LINE WAS SEPARATED DIRECTLY ADJACENT TO THE LUER HUB. REMAINS OF THE EXTENSION LINE WERE VISIBLE INSIDE THE SEPARATED LUER HUB. THE TOTAL LENGTH OF THE CATHETER BODY MEASURED TO BE 225 MM WHICH IS WITHIN THE SPECIFICATION OF 223-237 MM PER PRODUCT DRAWING. THE OUTER DIAMETER OF THE DISTAL LUMEN MEASURED TO BE 2.172 MM WHICH IS WITHIN SPECIFICATIONS OF 2.13-2.21 MM PER PRODUCT DRAWING. THE INNER DIAMETER OF THE DISTAL LUMEN MEASURED TO BE 1.47 MM WHICH IS WITHIN SPECIFICATIONS OF 1.42-1.50 MM PER PRODUCT DRAWING. THIS INDICATES THAT THE WALL THICKNESS MEASURED WITHIN SPECIFICATIONS. THE CATHETER WAS FUNCTIONALLY TESTED PER THE INSTRUCTIONS FOR USE (IFU). THE IFU PROVIDED WITH THIS KIT INSTRUCTS THE USER, "FLUSH EACH LUMEN WITH STERILE NORMAL SALINE FOR INJECTION TO ESTABLISH PATENCY AND PRIME LUMEN(S)." THE PROXIMAL AND MEDIAL LUMENS WERE FLUSHED USING A WATER-FILLED LAB INVENTORY SYRINGE. BIOLOGICAL MATERIAL EXITED BOTH LUMENS. AFTER THE BUILD-UP OF BIOLOGICAL WAS REMOVED , BOTH LUMENS FLUSHED AS EXPECTED. A MANUAL TUG TEST CONFIRMED THE PROXIMAL AND BOTH MEDIAL EXTENSION LINES WERE FULLY SECURED WITHIN THE LUER HUBS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT WARNS THE USER, "DO NOT APPLY EXCESSIVE FORCE IN PLACING OR REMOVING CATHETER OR GUIDEWIRE. EXCESSIVE FORCE CAN CAUSE COMPONENT DAMAGE OR BREAKAGE. IF DAMAGE IS SUSPECTED OR WITHDRAWAL CANNOT BE EASILY ACCOMPLISHED, RADIOGRAPHIC VISUALIZATION SHOULD BE OBTAINED AND FURTHER CONSULTATION REQUESTED. DO NOT SECURE, STAPLE AND/OR SUTURE DIRECTLY TO OUTSIDE DIAMETER OF CATHETER BODY OR EXTENSION LINES TO REDUCE RISK OF CUTTING OR DAMAGING THE CATHETER OR IMPEDING CATHETER FLOW. SECURE ONLY AT INDICATED STABILIZATION LOCATIONS. 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. A CAPA HAS PREVIOUSLY BEEN INITIATED DUE TO AN INCREASING TREND OF CVC EXTENSION LINE LEAKS AND SEPARATIONS. THE ROOT CAUSE OF THIS ISSUE HAS NOT YET BEEN DETERMINED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND COMPLAINTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    QN# (B)(4).

    Description of Event or Problem · 0

    THE CATHETER WAS PLACED ON (B)(6) 2021. ON (B)(6) 2021, THE LUER HUB OF THE DISTAL LUMEN DETACHED FROM THE EXTENSION LINE. THE CATHETER WAS REMOVED AND REPLACED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    THE CATHETER WAS PLACED ON (B)(6) 2021. ON (B)(6) 2021, THE LUER HUB OF THE DISTAL LUMEN DETACHED FROM THE EXTENSION LINE. THE CATHETER WAS REMOVED AND REPLACED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1839901 ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL INC. 71F20L1238

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NOT REPORTED| NOT REPORTED