BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW PI CVC KIT: 3L 7 FR X 16 CM AGB

    MDR report key: 23532416 · Received November 12, 2025

    Report

    Report Number
    9680794-2025-00912
    Event Type
    Injury
    Date Received
    November 12, 2025
    Date of Event
    October 14, 2025
    Report Date
    October 15, 2025
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    UDI-DI
    10801902117080
    PMA / PMN Number
    K071538
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER PROVIDED TWO PHOTOS FOR ANALYSIS. THE PHOTOS SHOW THE CATHETER HUB ATTACHED TO THE ARROW RAULERSON SYRINGE (ARS). THE CATHETER EXTRUSION WAS SEPARATED ADJACENT TO THE HUB, AND THE EXTRUSION WAS NOT SHOWN. THE CUSTOMER ALSO RETURNED THE CATHETER HUB FOR ANALYSIS. THE CATHETER BODY WAS NOT RETURNED. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WERE OBSERVED ON THE SAMPLE. VISUAL AND MICROSCOPIC ANALYSIS OF THE CATHETER BODY AT THE HUB REVEALED THE SEPARATION POINT WAS ROUGH AND JAGGED. CLEAR RESIDUE CONSISTENT WITH DRIED MEDICATION WAS OBSERVED WITHIN THE CATHETER. NO CUSTOMER RESPONSE WAS PROVIDED REGARDING WHETHER FLUIDS WERE FLUSHED THROUGH THE CATHETER. THE INNER DIAMETER OF THE CATHETER AT THE HUB MEASURED 0.039", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.039"-0.041" PER CATHETER EXTRUSION PRODUCT DRAWING. COMPLETE DIMENSIONAL ANALYSIS, INCLUDING THE OUTER DIAMETER, COULD NOT BE PERFORMED WITHOUT THE SEPARATED PORTION OF THE CATHETER RETURNED FOR ANALYSIS. FORCE WAS APPLIED TO THE PORTION OF THE CATHETER EXTRUSION THAT REMAINED ATTACHED TO THE CATHETER HUB TO DETERMINE IF THE MATERIAL WAS BRITTLE. THE MATERIAL DID NOT APPEAR BRITTLE TO SUGGEST A DEFECT IN THE STRUCTURAL INTEGRITY OF THE MATERIAL. THE CATHETER K-05600-030B CONTAINED WITHIN CATHETER OVER NEEDLE ASSEMBLY K-05600-024 CAN BE USED WITH AN ARS WITHOUT COMPLICATION. K-05600-030B IS DESIGNED WITH AN ISO COMPLIANT FEMALE LUER LOCK HUB. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT WARNS THE USER, "DO NOT SECURE, STAPLE AND/OR SUTURE DIRECTLY TO OUTSIDE DIAMETER OF CATHETER BODY OR EXTENSION LINES TO REDUCE RISK OF CUTTING OR DAMAGING THE CATHETER OR IMPEDING CATHETER FLOW. SECURE ONLY AT INDICATED STABILIZATION LOCATIONS." THE COMPLAINT OF CATHETER SEPARATION WAS CONFIRMED THROUGH INVESTIGATION OF THE RETURNED SAMPLE. VISUAL ANALYSIS REVEALED THE CATHETER BODY WAS SEPARATED ADJACENT TO THE CATHETER HUB AND THE SEPARATION POINT APPEARED ROUGH AND JAGGED. THE SEPARATED CATHETER BODY WAS NOT RETURNED. IT WAS DETERMINED THAT MANUFACTURING LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A NON-CONFORMANCE WAS INITIATED TO FURTHER INVESTIGATE THIS ISSUE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    IT WAS REPORTED "THE CATHETER BROKE OFF FROM THE BASE/TIP WITH NO RESISTANCE AND COULD NOT BE RETRIEVED UNDER THE PATIENT'S SKIN." THE CATHETER WAS REMOVED BY IR RETRIEVAL. THERE WAS NO SIGNS OR SYMPTOMS AFTER THE EVENT. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "STABLE AND DISCHARGED HOME".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2123255 ARROW PI CVC KIT: 3L 7 FR X 16 CM AGB CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL LLC 36F25A0006 10801902117080

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown NOT REPORTED