BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 23245324 · Received October 8, 2025

    Report

    Report Number
    3006425876-2025-00914
    Event Type
    Malfunction
    Date Received
    October 8, 2025
    Date of Event
    August 29, 2025
    Report Date
    September 15, 2025
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    UDI-DI
    10801902144444
    PMA / PMN Number
    K962577
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE DILATOR AND LIDSTOCK FOR ANALYSIS. NO SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WERE OBSERVED ON THE DILATOR. VISUAL ANALYSIS REVEALED THAT THE DILATOR TIP WAS SPLIT IN TWO LOCATIONS. MICROSCOPIC EXAMINATION REVEALED TWO SPLITS/CRACKS ON OPPOSITE SIDES OF THE DILATOR TIP. NO OBVIOUS EVIDENCE OF STRESS WERE OBSERVED, HOWEVER, THE DILATOR TIP WAS ASYMMETRICAL AT THE TIP DUE TO THE DAMAGE. THE DILATOR LENGTH MEASURED 3 15/16", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 3 3/4" - 4 1/4" PER THE DILATOR PRODUCT DRAWING. THE INNER DIAMETER OF THE DILATOR AT THE PROXIMAL END MEASURED .041" , WHICH IS WITHIN THE SPECIFICATION LIMITS OF .041" - .043" PER THE DILATOR PRODUCT DRAWING. THE INNER DIAMETER OF THE DILATOR AT THE DISTAL TIP COULD NOT BE ACCURATELY MEASURED DUE TO THE NATURE OF THE DAMAGE. A LAB INVENTORY GUIDEWIRE (.032" DIAMETER) WAS THREADED THROUGH THE DISTAL END OF THE RETURNED DILATOR. THE GUIDEWIRE PASSED WITH NO RESISTANCE. PERFORMED PER IFU STATEMENT, "USE TISSUE DILATOR TO ENLARGE TISSUE TRACT TO THE VEIN AS REQUIRED. FOLLOW THE ANGLE OF THE GUIDEWIRE SLOWLY THROUGH THE SKIN." A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "DO NOT USE EXCESSIVE FORCE WHEN INTRODUCING GUIDEWIRE OR TISSUE DILATOR AS THIS CAN LEAD TO VESSEL PERFORATION, BLEEDING, OR COMPONENT DAMAGE". THE CUSTOMER REPORT OF DILATOR TIP BEING DAMAGED DURING USE WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. VISUAL ANALYSIS REVEALED THAT THE DILATOR TIP WAS SPLIT IN TWO LOCATIONS ON OPPOSITE SIDES OF THE TIP OPENING. R & D ENGINEERING, CLINICAL AND MEDICAL AFFAIRS (CMA), AND THE MANUFACTURING TEAM WERE CONSULTED REGARDING THIS COMPLAINT. A CROSS-FUNCTIONAL REVIEW OF THE RETURNED SAMPLE DETERMINED THAT THE DAMAGE OBSERVED IS INCONSISTENT WITH THAT RESULTING FROM CLINICIAN USE ALONE. THE MANUFACTURING TEAM CONFIRMED THAT THEY HAVE NOT SEEN THIS TYPE OF DAMAGE PRESENTED ON A DILATOR. BASED ON THESE CIRCUMSTANCES, THE ROOT CAUSE IS UNDETERMINED, HOWEVER, A NON-CONFORMANCE WAS INITIATED TO FURTHER INVESTIGATE THIS ISSUE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND INCISION WAS MADE DEEPER THAN USUAL, AND THE TIP OF THE TISSUE DILATOR WAS FOUND TO BE DAMAGED AFTER INSERTING IT ONCE. THE SECOND PRODUCT WAS ALSO DAMAGED AND RECEIVED. SO, THE MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE". THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00915 AND 3006425876-2025-00914.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "DURING THE PROCEDURE ACCORDING TO IFU, THE MD FOUND INCISION WAS MADE DEEPER THAN USUAL, AND THE TIP OF THE TISSUE DILATOR WAS FOUND TO BE DAMAGED AFTER INSERTING IT ONCE. THE SECOND PRODUCT WAS ALSO DAMAGED AND RECEIVED. SO, THE MD OPENED UP THE NEW KIT TO FINISH THE PROCEDURE". THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE". ASSOCIATED MDR NUMBERS INCLUDE: 3006425876-2025-00915.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2610075 ARROW CVC SET: 4-LUMEN 8.5 FR X 20 CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL LLC 71F25E0858 10801902144444

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED.