BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 3-LUMEN 12 FR X 20 CM

    MDR report key: 14246190 · Received April 28, 2022

    Report

    Report Number
    3006425876-2022-00378
    Event Type
    Malfunction
    Date Received
    April 28, 2022
    Date of Event
    April 7, 2022
    Report Date
    April 7, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER; THEREFORE, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED UPON A LOT NUMBER FROM THE SALES HISTORY DATA OF THE CUSTOMER. NO RELEVANT FINDINGS WERE IDENTIFIED. 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 "THE LUER-HUB (BROWN) WAS FALLING OFF". NO PATIENT HARM. THE DEVICE WAS REPLACED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED "THE LUER-HUB (BROWN) WAS FALLING OFF". NO PATIENT HARM. THE DEVICE WAS REPLACED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    110127 ARROW CVC SET: 3-LUMEN 12 FR X 20 CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL LLC

    Patients

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