BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17246370 · Received July 3, 2023

    Report

    Report Number
    3006425876-2023-00614
    Event Type
    Malfunction
    Date Received
    July 3, 2023
    Date of Event
    April 18, 2023
    Report Date
    June 5, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    UDI-DI
    10801902029390
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER REPORT OF SWG UNRAVELED WAS CONFIRMED BY VISUAL INSPECTION OF THE CUSTOMER SUPPLIED PHOTOS. THE IMAGES SHOWED AN UNRAVELED GUIDEWIRE ADVANCED THROUGH A CATHETER WITH EVIDENCE OF USE. HOWEVER, FULL COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. 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." A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: "ATTEMPT IS MADE FOR INSERTION THROUGH THE RIGHT SUBCLAVIAN USING ANATOMICAL LANDMARKS. SELDINGER TECHNIQUE IS PERFORMED WITH A SINGLE NEEDLE PASS. VENOUS RETURN IS ACHIEVED ON THE FIRST ATTEMPT. METALLIC GUIDE WIRE IS ADVANCED, FOLLOWED BY DILATOR INSERTION AND PASSAGE OF A TRILUMEN CATHETER. UPON RETRIEVAL OF THE METALLIC GUIDE WIRE, IT BECOMES KINKED, REQUIRING REPLACEMENT OF THE CENTRAL VENOUS CATHETER SET DUE TO PRODUCT DEFECT. A NEW SUBCLAVIAN PUNCTURE IS PERFORMED WITH LOSS OF RESISTANCE, BUT VASCULAR ACCESS IS NOT ACHIEVED. A SECOND ATTEMPT IS MADE AND IT IS DECIDED TO PERFORM RIGHT JUGULAR CVC PLACEMENT, AND THE CVC IS SUCCESSFULLY INSERTED" NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: "ATTEMPT IS MADE FOR INSERTION THROUGH THE RIGHT SUBCLAVIAN USING ANATOMICAL LANDMARKS. SELDINGER TECHNIQUE IS PERFORMED WITH A SINGLE NEEDLE PASS. VENOUS RETURN IS ACHIEVED ON THE FIRST ATTEMPT. METALLIC GUIDE WIRE IS ADVANCED, FOLLOWED BY DILATOR INSERTION AND PASSAGE OF A TRILUMEN CATHETER. UPON RETRIEVAL OF THE METALLIC GUIDE WIRE, IT BECOMES KINKED, REQUIRING REPLACEMENT OF THE CENTRAL VENOUS CATHETER SET DUE TO PRODUCT DEFECT. A NEW SUBCLAVIAN PUNCTURE IS PERFORMED WITH LOSS OF RESISTANCE, BUT VASCULAR ACCESS IS NOT ACHIEVED. A SECOND ATTEMPT IS MADE AND IT IS DECIDED TO PERFORM RIGHT JUGULAR CVC PLACEMENT, AND THE CVC IS SUCCESSFULLY INSERTED". NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1343483 ARROW CVC SET: 3-LUMEN 7FR X 20CM CATHETER,INTRAVASCULAR,THERAP FOZ ARROW INTERNATIONAL LLC IPN030935 71F21J1035 10801902029390

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female NOT REPORTED| NOT REPORTED