BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14353812 · Received May 11, 2022

    Report

    Report Number
    3006425876-2022-00453
    Event Type
    Malfunction
    Date Received
    May 11, 2022
    Date of Event
    April 14, 2022
    Report Date
    April 18, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED MULTIPLE COMPONENTS FROM A CVC KIT. 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 NEEDLE HUB. VISUAL ANALYSIS REVEALED THAT THE INTRODUCER NEEDLE HUB WAS CRACKED. MICROSCOPIC ANALYSIS CONFIRMED THE DAMAGE AND REVEALED THAT THE OUTSIDE OF THE HUB CONTAINED SCRATCH MARKS. THE NEEDLE LENGTH (PER MEASUREMENT A IN THE CANNULA PRODUCT DRAWING) MEASURED 2.756" WHICH IS WITHIN THE SPECIFICATION LIMITS OF 2.732"-2.792". THE CANNULA OUTER DIAMETER MEASURED .0498" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .0495"-.0505" PER THE CANNULA PRODUCT DRAWING. THE CANNULA INNER DIAMETER AT THE DISTAL AND PROXIMAL ENDS MEASURED .041" WHICH IS WITHIN THE SPECIFICATION LIMITS OF .041"-.043" PER THE CANNULA PRODUCT DRAWING. THE RETURNED INTRODUCER NEEDLE WAS ATTACHED TO THE ARS. THE ASSEMBLY WAS THEN USED TO DRAW AND ASPIRATE WATER. NO LEAKS OR ANOMALIES WERE OBSERVED AS THE ASSEMBLY WAS ABLE TO DRAW AND ASPIRATE WATER. THIS INDICATES THAT THE SMALL CRACKS DO REACH THE OUTER SURFACE OF THE HUB. ADDITIONALLY, THE SMALL CRACKS DO NOT APPEAR TO AFFECT THE FUNCTIONALITY OF THE DEVICE. PERFORMED PER IFU STATEMENT "INSERT INTRODUCER NEEDLE OR CATHETER/NEEDLE WITH ATTACHED SYRINGE OR ARROW RAULERSON SYRINGE (WHERE PROVIDED) INTO VEIN AND ASPIRATE". A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE REPORT OF A CRACKED NEEDLE HUB WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL ANALYSIS REVEALED THAT THE NEEDLE HUB WAS SLIGHTLY CRACKED. DESPITE THIS, THE NEEDLE MET ALL RELEVANT DIMENSION AND FUNCTIONAL REQUIREMENTS, AND A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH NO RELEVANT FINDINGS WERE IDENTIFIED. IT WAS DETERMINED THAT THE ROOT CAUSE FOR THIS ISSUE IS DESIGN RELATED. A CAPA HAS BEEN INITIATED TO FURTHER INVESTIGATE THIS COMPLAINT ISSUE. THE HUB FROM THE REPORTED KIT WAS MANUFACTURED PRIOR TO CAPA IMPLEMENTATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE NEEDLE FROM THE RAULERSON SYRINGE FELL OFF. A NEW KIT WAS OPENED TO FINISH THE PROCEDURE. NO PATIENT HARM. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING THE PROCEDURE, THE NEEDLE FROM THE RAULERSON SYRINGE FELL OFF. A NEW KIT WAS OPENED TO FINISH THE PROCEDURE. NO PATIENT HARM. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    644061 ARROW CVC SET: 3-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL LLC 71F21F2502

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown