BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17768488 · Received September 18, 2023

    Report

    Report Number
    3006425876-2023-00908
    Event Type
    Malfunction
    Date Received
    September 18, 2023
    Date of Event
    August 23, 2023
    Report Date
    August 24, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SF
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (B)(4). ASSOCIATED MDR#S 3006425876-2023-00907; 3006425876-2023-00908. COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND 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.

    Additional Manufacturer Narrative · 0

    QN#(B)(4). ASSOCIATED MDR#S 3006425876-2023-00907.

    Description of Event or Problem · 0

    PHYSICIAN REPORTED WHEN TRYING TO ASPIRATE THROUGH THE INTRODUCER NEEDLE WITH THE RAULERSON SYRINGE, HE NOTICED HE WAS ASPIRATING SOME AIR AND NOTICED A CRACK IN THE HUB. HE THEN DISCARDED THE SET AND OPENED A NEW ONE. HE ENCOUNTERED THE SAME ISSUE WITH THE SECOND SET SO OPENED A THIRD SET. THE THIRD SET WAS SUCCESSFULLY USED AND CATHETER PLACED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS "FINE".

    Description of Event or Problem · 0

    PHYSICIAN REPORTED WHEN TRYING TO ASPIRATE THROUGH THE INTRODUCER NEEDLE WITH THE RAULERSON SYRINGE, HE NOTICED HE WAS ASPIRATING SOME AIR AND NOTICED A CRACK IN THE HUB. HE THEN DISCARDED THE SET AND OPENED A NEW ONE. HE ENCOUNTERED THE SAME ISSUE WITH THE SECOND SET SO OPENED A THIRD SET. THE THIRD SET WAS SUCCESSFULLY USED AND CATHETER PLACED. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS "FINE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1257018 ARROW CVC SET: 3-LUMEN 7FR X 20CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL LLC 71F23A1695

    Patients

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