BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 3-LUMEN 12 FR X 16 CM

    MDR report key: 13964505 · Received March 31, 2022

    Report

    Report Number
    3006425876-2022-00270
    Event Type
    Malfunction
    Date Received
    March 31, 2022
    Date of Event
    March 9, 2022
    Report Date
    March 9, 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

    QN#: (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. FOR MATERIALS KZ-43122-UNW, 002200-014040, A NON-CONFORMANCE WAS INITIATED FOR LOT 71C20H0946 RELATED TO SMALLER INNER DIAMETER OF TUBES. 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

    THE COMPLAINT IS REPORTED AS "THE DILATOR SPLITED". NO PATIENT HARM REPORTED. THE DEVICE WAS REPLACED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS "THE DILATOR SPLITED". NO PATIENT HARM REPORTED. THE DEVICE WAS REPLACED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1107419 ARROW CVC SET: 3-LUMEN 12 FR X 16 CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL LLC 71F21B2680

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown