BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW MULTILUMEN PI CVC KIT: 3L 7 FR X 16 CM

    MDR report key: 17662514 · Received August 31, 2023

    Report

    Report Number
    9680794-2023-00616
    Event Type
    Malfunction
    Date Received
    August 31, 2023
    Date of Event
    July 11, 2023
    Report Date
    August 8, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    UDI-DI
    10801902117073
    PMA / PMN Number
    K071538
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DE, US
    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 IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THE KIT WAS LABELED WITH CDC-42703-P1A (16CM) CATHETER, HAD A 20CM CATHETER IN IT AND NO 16CM CATHETER. THE ISSUE WAS DETECTED AFTER THE CATHETER WAS PLACED WHEN REVIEWING THE X-RAY. THE PROVIDER HAD TO PULL THE CVC BACK AND HAVE ABOUT 5CM OF CATHETER STICKING OUT. THE CATHETER WAS INSERTED IN THE RIGHT IJ. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE KIT WAS LABELED WITH CDC-42703-P1A (16CM) CATHETER, HAD A 20CM CATHETER IN IT AND NO 16CM CATHETER. THE ISSUE WAS DETECTED AFTER THE CATHETER WAS PLACED WHEN REVIEWING THE X-RAY. THE PROVIDER HAD TO PULL THE CVC BACK AND HAVE ABOUT 5CM OF CATHETER STICKING OUT. THE CATHETER WAS INSERTED IN THE RIGHT IJ. NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1262828 ARROW MULTILUMEN PI CVC KIT: 3L 7 FR X 16 CM CATHETER INTRAVASCULAR THERAP FOZ ARROW INTERNATIONAL LLC 13F22C0033 10801902117073

    Patients

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