BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC KIT: 3-LUMEN 8,5FR X 20CM

    MDR report key: 24495211 · Received March 3, 2026

    Report

    Report Number
    3006425876-2026-00237
    Event Type
    Malfunction
    Date Received
    March 3, 2026
    Date of Event
    February 2, 2026
    Report Date
    February 4, 2026
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    UDI-DI
    10801902212761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE 18GA INTRODUCER NEEDLE AND A BD SYRINGE (K-09805-002A) FOR ANALYSIS. DEFINITE SIGNS OF USE WERE OBSERVED. VISUAL ANALYSIS REVEALED THE NEEDLE HUB CONTAINED ONE LARGE VERTICAL CRACK. A SECONDARY, SMALLER CRACK WAS ALSO OBSERVED ON THE NEEDLE HUB. MICROSCOPIC EXAMINATION CONFIRMED THE CRACKS IN THE NEEDLE HUB. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE CUSTOMER REPORT OF NEEDLE HUB CRACKED WAS CONFIRMED BY EVALUATION OF THE RETURNED SAMPLE. VISUAL ANALYSIS REVEALED MULTIPLE CRACKS IN THE NEEDLE HUB. THE FAILURE MODE IDENTIFIED IS CONSISTENT WITH THE FAILURE MODE INVESTIGATED PER A PREVIOUSLY OPENED CAPA. BASED ON THE CAPA INVESTIGATION, THE ROOT CAUSE OF THIS COMPLAINT IS DESIGN RELATED. TELEFLEX HAS IDENTIFIED THAT THIS 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. THE CAPA WAS IMPLEMENTED USING A NEW ALCOHOL RESISTANT MATERIAL TO MANUFACTURE THE NEEDLE HUB. THE NEEDLE HUB FROM THIS COMPLAINT WAS CONFIRMED TO BE MADE FROM THE OLD NEEDLE HUB MATERIAL. 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 "THE PUNCTURE NEEDLE IS LEAKING." THE USER STATED THE CONE OF THE CANNULA WAS DEFECTIVE WHICH CAUSED THE LEAK. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE PUNCTURE NEEDLE IS LEAKING." THE USER STATED THE CONE OF THE CANNULA WAS DEFECTIVE WHICH CAUSED THE LEAK. THERE WAS NO PATIENT HARM OR INJURY. NO MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211452 ARROW CVC KIT: 3-LUMEN 8,5FR X 20CM CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL LLC IPN926620 71F25B1096 10801902212761

    Patients

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