BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14162237 · Received April 20, 2022

    Report

    Report Number
    3006425876-2022-00320
    Event Type
    Malfunction
    Date Received
    April 20, 2022
    Date of Event
    March 23, 2022
    Report Date
    March 29, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4).

    Additional Manufacturer Narrative · 0

    (B)(4). THE CUSTOMER RETURNED ONE, SEPARATED MEDIAL LUER HUB AND A NON-ARROW CONNECTOR TUBING FOR ANALYSIS. SIGNS OF USE IN THE FORM OF BIOLOGICAL MATERIAL WERE OBSERVED INSIDE THE CONNECTOR TUBING. VISUAL ANALYSIS REVEALED THAT THE MEDIAL EXTENSION LINE HAD SEPARATED WITHIN THE MEDIAL LUER HUB (BLUE HUB). THE LUER HUB WAS CROSS SECTIONED TO OBSERVE THE INSIDE OF THE LUER HUB. VISUAL AND MICROSCOPIC EXAMINATION REVEALED THAT A PORTION OF THE EXTENSION LINE WAS STILL WITHIN THE LUER HUB. ADDITIONALLY, THE POINT OF SEPARATION APPEARED JAGGED AND ROUGH. DESPITE THIS, A FULL VISUAL ANALYSIS COULD NOT BE PERFORMED ON THE REST OF THE MEDIAL EXTENSION LINE/CATHETER AS IT WAS NOT RETURNED FOR ANALYSIS. THE MANUFACTURING FACILITY WAS CONTACTED AS PART OF THIS COMPLAINT INVESTIGATION. THEY INDICATED THAT THEY HAVE NOT SEEN THIS TYPE OF DEFECT BEFORE AND THAT IT IS DIFFICULT TO DETERMINE A ROOT CAUSE WITHOUT THE ENTIRE CATHETER RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED, AND NO RELEVANT FINDINGS WERE IDENTIFIED. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "DO NOT APPLY EXCESSIVE FORCE IN PLACING OR REMOVING CATHETER OR GUIDEWIRE. EXCESSIVE FORCE CAN CAUSE COMPONENT DAMAGE OR BREAKAGE. IF DAMAGE IS SUSPECTED OR WITHDRAWAL CANNOT BE EASILY ACCOMPLISHED, RADIOGRAPHIC VISUALIZATION SHOULD BE OBTAINED AND FURTHER CONSULTATION REQUESTED". THE REPORT OF AN EXTENSION LINE/LUER HUB SEPARATION WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION. VISUAL AND MICROSCOPIC ANALYSIS REVEALED THAT THE MEDIAL EXTENSION LINE SEPARATED WITHIN THE MEDIAL LUER HUB. BASED ON THE CUSTOMER REPORT, THE SAMPLE RECEIVED, AND THE COMMENTS FROM MANUFACTURING, THE ROOT CAUSE CANNOT BE DETERMINED WITHOUT THE ENTIRE CATHETER RETURNED FOR ANALYSIS. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: "INCIDENT HAPPENED ON THE (B)(6) 2022 AT 7.20AM IN THE RESCUCITATION DEPARTMENT, INVOLVED A FEMALE PATIENT. THE MEDIAL LINE OF THE CVC SEPARATED SPONTANEOUSLY IN USE WITHOUT ANY MOVEMENT OF THE PATIENT. THE CENTRAL LINE OF THE CATHETER WAS NOT MOVED NEITHER. THE NURSE HEARD A NOISE LIKE A "POP" WHEN IT SEPARATED. THE LINE WAS CLAMPED, AN INFUSION/DRIP LINE WAS INSERTED, THE CVC WAS REMOVED." NO PATIENT HARM OR CONSEQUENCE REPORTED.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: "INCIDENT HAPPENED ON THE 23 MARCH 2022 AT 7.20AM IN THE RESCUCITATION DEPARTMENT, INVOLVED A FEMALE PATIENT. THE MEDIAL LINE OF THE CVC SEPARATED SPONTAENOUSLY IN USE WITHOUT ANY MOVEMENT OF THE PATIENT. THE CENTRAL LINE OF THE CATHETER WAS NOT MOVED NEITHER. THE NURSE HEARD A NOISE LIKE A "POP" WHEN IT SEPARATED. THE LINE WAS CLAMPED, AN INFUSION/DRIP LINE WAS INSERTED, THE CVC WAS REMOVED." NO PATIENT HARM OR CONSEQUENCE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272696 ARROW CVC SET: 3-LUMEN 7 FR X 20 CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL LLC IPN918764 71F21J1987

    Patients

    Seq Age Sex Outcome Treatment
    1 Female