BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 3-LUMEN 8.5FR X 20CM

    MDR report key: 13581452 · Received February 22, 2022

    Report

    Report Number
    3006425876-2022-00167
    Event Type
    Malfunction
    Date Received
    February 22, 2022
    Date of Event
    February 2, 2022
    Report Date
    February 3, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    UDI-DI
    10801902029017
    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). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED WITH ONE RELEVANT FINDING IDENTIFIED. FOR MATERIAL MCZ-15853-008A, LOT 72C20A0140, A NON-CONFORMANCE WAS INITIATED FOR TO ADDRESS THE ISSUE OF "SWG DOES NOT GO FREELY THROUGHOUT JUNCTURE HUB". WITHOUT THE DEVICE TO EVALUATE THE COMPLAINT COULD NOT BE CONFIRMED AND THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED IT WAS DIFFICULT TO ADVANCE THE CATHETER ON THE GUIDE. THE CATHETER WAS BLOCKED AND THAT KINKED THE GUIDE. THE CATHETER WAS REMOVED AND THE SAME GUIDE WAS USED TO INSERT A NEW CATHETER AT THE SAME INSERTION SITE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED IT WAS DIFFICULT TO ADVANCE THE CATHETER ON THE GUIDE. THE CATHETER WAS BLOCKED AND THAT KINKED THE GUIDE. THE CATHETER WAS REMOVED AND THE SAME GUIDE WAS USED TO INSERT A NEW CATHETER AT THE SAME INSERTION SITE. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    686340 ARROW CVC SET: 3-LUMEN 8.5FR X 20CM CATHETER, PERCUTANEOUS DQY ARROW INTERNATIONAL LLC IPN030779 71F20B0830 10801902029017

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown