BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW MULTILUMEN/PSI KIT 9 FR X 11.5 CM

    MDR report key: 17912902 · Received October 11, 2023

    Report

    Report Number
    9680794-2023-00778
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Date of Event
    January 2, 2023
    Report Date
    September 14, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    UDI-DI
    10801902112054
    PMA / PMN Number
    K011761
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    MEDWATCH FORM RECEIVED REPORTS: "LEFT INTERNAL JUGULAR (LIJ) 9 FR INTRODUCER (DOUBLE LUMEN (DL)) WITH PULMONARY ARTERY CATHETER (PA) TO INTRODUCER PLACED ULTRASOUND (US) GUIDED AND THEN REMOVED SIX DAYS LATER. EXTRAVASATED AND LEFT NECK ECCHYMOSIS, BLACK COLOR. EXTRAVASATION PROTOCOL HAD BEEN DONE. LINE REMOVED-PLASTIC SURGERY FOLLOWING PATIENT. LINE NOT SAVED ".

    Description of Event or Problem · 0

    MEDWATCH FORM RECEIVED REPORTS: "LEFT INTERNAL JUGULAR (LIJ) 9 FR INTRODUCER (DOUBLE LUMEN (DL)) WITH PULMONARY ARTERY CATHETER (PA) TO INTRODUCER PLACED ULTRASOUND (US) GUIDED AND THEN REMOVED SIX DAYS LATER. EXTRAVASATED AND LEFT NECK ECCHYMOSIS, BLACK COLOR. EXTRAVASATION PROTOCOL HAD BEEN DONE. LINE REMOVED-PLASTIC SURGERY FOLLOWING PATIENT. LINE NOT SAVED ".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1180893 ARROW MULTILUMEN/PSI KIT 9 FR X 11.5 CM CATHETER,INTRAVASCULAR,THERAP FOZ ARROW INTERNATIONAL LLC UNKNOWN 10801902112054

    Patients

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