BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW EXT DWELL CATH DEVICE 20GAX6CM

    MDR report key: 7828420 · Received August 29, 2018

    Report

    Report Number
    9680794-2018-00180
    Event Type
    Malfunction
    Date Received
    August 29, 2018
    Date of Event
    August 10, 2018
    Report Date
    August 13, 2018
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    FOZ
    PMA / PMN Number
    K151513
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED A CATHETER ASSEMBLY FROM AN ENDURANCE DEVICE FOR EVALUATION. THE CATHETER WAS RETURNED DETACHED FROM THE ENDURANCE DEVICE AND THE CATHETER BODY WAS SEPARATED IN TWO PIECES NEAR THE DISTAL END. IN ADDITION, THE NEEDLE GUARD WAS ON THE DISTAL END OF THE INTRODUCER NEEDLE. VISUAL EXAMINATION OF THE SEPARATION POINT OF THE CATHETER REVEALED BOTH SEPARATED EDGES WERE SMOOTH, WHICH IS CONSISTENT WITH DAMAGE RESULTING FROM CONTACT WITH THE NEEDLE BEVEL. DRIED BLOOD WAS OBSERVED WITHIN THE CATHETER BODY BUT NO OTHER DAMAGE TO THE CATHETER WAS OBSERVED. THE PROXIMAL END OF THE SEPARATED CATHETER BODY MEASURED 1.61417" IN LENGTH AND THE DISTAL END OF THE SEPARATED CATHETER BODY MEASURED .984252" IN LENGTH (APPROXIMATELY 2.598" TOTAL). THE CATHETER LENGTH SPECIFICATION IS 2.594"-2.604" PER CATHETER DRAWING; THEREFORE, THE CATHETER MET THE ORIGINAL LENGTH SPECIFICATIONS. THE CATHETER BODY INNER AND OUTER DIAMETER WAS ALSO WITHIN SPECIFICATION. THE CATHETER WAS FLUSHED WITH WATER AND FUNCTIONED AS EXPECTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO MANUFACTURING ISSUES WERE IDENTIFIED. THE CURRENT INSTRUCTIONS-FOR-USE (IFU) PROVIDED WITH THIS KIT GIVES INSTRUCTIONS FOR PROPER TECHNIQUES WHILE INSERTING THE CATHETER. IT CAUTIONS THE USER TO "ALWAYS KEEP NEEDLE/HANDLE STATIONARY WHILE THREADING CATHETER. DO NOT RETRACT NEEDLE/HANDLE WHILE THREADING CATHETER. FAILURE TO KEEP NEEDLE/ HANDLE STATIONARY MAY PREVENT CATHETER FROM THREADING INTO VESSEL." THE IFU ALSO CAUTIONS "DO NOT FORCE CATHETER IF RESISTANCE IS ENCOUNTERED DURING ADVANCEMENT." THE CUSTOMER REPORT THAT THE CATHETER BODY SEPARATED WAS CONFIRMED THROUGH VISUAL EXAMINATION OF THE RETURNED SAMPLE. THE CATHETER BODY WAS RETURNED SEPARATED IN TWO PIECES AND THE SEPARATION POINT WAS CONSISTENT WITH DAMAGE DUE TO CONTACT WITH THE NEEDLE BEVEL. THE CATHETER MET ALL RELEVANT DIMENSIONAL REQUIREMENTS AND NO MANUFACTURING ISSUES WERE IDENTIFIED DURING A DEVICE HISTORY RECORD REVIEW. BASED ON THE CONDITION OF THE RETURNED SAMPLE AND THE CUSTOMER REPORT, IT WAS DETERMINED THAT OPERATIONAL CONTEXT 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: VASCULAR ACCESS TEAM WENT TO A PATIENT'S BEDSIDE TO PLACE AN EXTENDED DWELL CATHETER FOR 7-10 DAYS OF ANTIBIOTICS. UPON INSERTION UNDER ULTRASOUND GUIDANCE THE 4CM WIRE ADVANCED WITHOUT DIFFICULTLY, THEN WHEN THE CATHETER WAS ADVANCED RESISTANCE WAS MET. THE CATHETER WAS THEN REMOVED AND SET ASIDE. THE VASCULAR ACCESS NURSE NOTICED THAT THE END OF THE ENDURANCE CATHETER WAS MISSING APPROXIMATELY 2.5CM. THE PATIENT WAS RE-EXAMINED USING ULTRASOUND AND THE TIP OF THE CATHETER WAS FOUND IN THE CEPHALIC VEIN. PATIENT WAS THEN SENT TO SURGERY TO HAVE THE TIP REMOVED VIA SUBCUTANEOUS TAKE DOWN.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    THE CUSTOMER REPORTS: VASCULAR ACCESS TEAM WENT TO A PATIENT'S BEDSIDE TO PLACE AN EXTENDED DWELL CATHETER FOR 7-10 DAYS OF ANTIBIOTICS. UPON INSERTION UNDER ULTRASOUND GUIDANCE THE 4 CM WIRE ADVANCED WITHOUT DIFFICULTLY, THEN WHEN THE CATHETER WAS ADVANCED RESISTANCE WAS MET. THE CATHETER WAS THEN REMOVED AND SET ASIDE. THE VASCULAR ACCESS NURSE NOTICED THAT THE END OF THE ENDURANCE CATHETER WAS MISSING APPROXIMATELY 2.5 CM. THE PATIENT WAS RE-EXAMINED USING ULTRASOUND AND THE TIP OF THE CATHETER WAS FOUND IN THE CEPHALIC VEIN. PATIENT WAS THEN SENT TO SURGERY TO HAVE THE TIP REMOVED VIA SUBCUTANEOUS TAKE DOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    667115 ARROW EXT DWELL CATH DEVICE 20GAX6CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL INC. 14F17J0110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention