BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET

    MDR report key: 15784837 · Received November 11, 2022

    Report

    Report Number
    3006425876-2022-00976
    Event Type
    Malfunction
    Date Received
    November 11, 2022
    Date of Event
    October 19, 2022
    Report Date
    October 19, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    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 INTRODUCER NEEDLE FOR ANALYSIS. NO DEFINITE SIGNS OF USE WERE OBSERVED. VISUAL ANALYSIS REVEALED THAT THE NEEDLE HUB WAS BROKEN AND SEPARATED. A PORTION OF THE DISTAL END OF THE HUB WAS STILL ADHERED TO THE NEEDLE CANNULA. MICROSCOPIC EXAMINATION REVEALED THAT THE POINT OF SEPARATION WAS MOSTLY SMOOTH. BASED ON VISUAL INSPECTION OF THE HUB AND THE POTENTIAL FINISHED GOOD MATERIAL NUMBERS PROVIDED, THE DESIGN OF THE NEEDLE HUB MATCHES MATERIAL NUMBERS K-04300-019C AND/OR K-04300-019B, BOTH OF WHICH ARE INCLUDED WITHIN THE SCOPE OF A CAPA. FUNCTIONAL INSPECTION WAS NOT ABLE TO BE PERFORMED DUE TO THE DAMAGE TO THE NEEDLE HUB. THE CUSTOMER REPORT OF A CRACKED NEEDLE HUB WAS CONFIRMED THROUGH VISUAL INSPECTION OF THE RETURNED SAMPLE. VISUAL EXAMINATION REVEALED THE HUB WAS SEPARATED. BASED ON THESE CIRCUMSTANCES AND THE COMMENTS FROM R & D, THE ROOT CAUSE OF THIS COMPLAINT 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. INVESTIGATION OF THIS ISSUE IS DOCUMENTED UNDER A CAPA. CORRECTIVE ACTIONS HAVE NOT YET BEEN IMPLEMENTED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    QN#(B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE NEEDLE CONE HAS DETACHED FROM THE METAL NEEDLE" DURING USE. THE PUNCTURE SITE WAS THE SUBCLAVIAN VEIN. THE NEEDLE WAS "SIMPLY PULLED OUT" OF THE PATIENT. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT "THE NEEDLE CONE HAS DETACHED FROM THE METAL NEEDLE" DURING USE. THE PUNCTURE SITE WAS THE SUBCLAVIAN VEIN. THE NEEDLE WAS "SIMPLY PULLED OUT" OF THE PATIENT. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2705544 ARROW CVC SET CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown OCTENIDERM SPRAY DISINFECTANT.| OCTENIDERM SPRAY DISINFECTANT.