BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17646384 · Received August 29, 2023

    Report

    Report Number
    3006425876-2023-00838
    Event Type
    Malfunction
    Date Received
    August 29, 2023
    Date of Event
    August 7, 2023
    Report Date
    August 7, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AU
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE, OPENED CVC KIT FOR ANALYSIS. THE ARROW RAULERSON SYRINGE (ARS) AND THE INTRODUCER NEEDLE WILL BE ANALYZED AS PART OF THIS COMPLAINT INVESTIGATION. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WERE OBSERVED INSIDE THE ARS. VISUAL ANALYSIS OF THE INTRODUCER NEEDLE REVEALED SEVERAL LATERAL CRACKS ON THE HUB. MICROSCOPIC EXAMINATION CONFIRMED THE CRACKS AND REVEALED THEY WERE EMANATING FROM THE PROXIMAL LUER OPENING. IT WAS CONFIRMED THAT THE HUB ON THE RETURNED SAMPLE IS THE K-04300-019C HUB DESIGN, WHICH MATCHES THE BILL OF MATERIALS. THE NEEDLE WAS ATTACHED TO THE RETURNED ARS AND FUNCTIONALLY TESTED PER THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT, WHICH STATES "INSERT INTRODUCER NEEDLE OR CATHETER/NEEDLE WITH ATTACHED SYRINGE OR ARROW RAULERSON SYRINGE (WHERE PROVIDED) INTO VEIN AND ASPIRATE". THE SYRINGE WAS NOT ABLE TO DRAW AND ASPIRATE WATER WHEN ATTACHED TO THE RETURNED INTRODUCER NEEDLE. WATER WAS OBSERVED TO LEAK OUT OF THE CRACK IN THE NEEDLE HUB. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED TO SUGGEST A MANUFACTURING RELATED ISSUE. THE CUSTOMER REPORT OF A CRACKED NEEDLE HUB WAS CONFIRMED THROUGH VISUAL INSPECTION OF THE RETURNED SAMPLE. THE RETURNED NEEDLE WAS CONFIRMED TO HAVE SEVERAL CRACKS IN THE BODY OF THE HUB. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO FININGS TO SUGGEST A MANUFACTURING RELATED ISSUE. FURTHER INVESTIGATION OF THIS ISSUE IS BEING PERFORMED UNDER A CAPA. THE CAPA INVESTIGATION INDICATES THE ROOT CAUSE IS DESIGN RELATED. TELEFLEX HAS IDENTIFIED THAT THE NEEDLE HUB MATERIAL IS SUSCEPTIBLE TO CRACKING WHEN PLACED UNDER STRESS (I.E. PRESSED ONTO A TAPERED LUER FITTING, SIDELOADED AS THE CLINICIAN ATTEMPTS TO LOCATE A VESSEL, ETC.) IN THE PRESENCE OF LIQUID ALCOHOL-BASED DISINFECTANTS. CORRECTIVE ACTIONS HAVE NOT YET BEEN FULLY IMPLEMENTED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE HUB OF THE PUNCTURE NEEDLE IS FAULTY. THE SYRINGE FALLS OFF/IS NOT PROPERLY FIXED AND AIR ASPIRATED." ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE HUB OF THE PUNCTURE NEEDLE IS FAULTY. THE SYRINGE FALLS OFF/IS NOT PROPERLY FIXED AND AIR ASPIRATED." ADDITIONAL INFORMATION WAS REQUESTED BUT NOT RECEIVED AT THE TIME OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2086099 ARROW CVC SET: 4-LUMEN 8.5FR X 20CM CATHETER, INTRAVASCULAR, THERAPEUTIC FOZ ARROW INTERNATIONAL LLC IPN916866 71F23A1533

    Patients

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