BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 14160757 · Received April 20, 2022

    Report

    Report Number
    3006425876-2022-00332
    Event Type
    Injury
    Date Received
    April 20, 2022
    Date of Event
    March 23, 2022
    Report Date
    March 23, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). PHYSICIAN REPORTED THE PATIENT DIED UNRELATED TO THE DEVICE OR PNEUMOTHORAX. THE CUSTOMER WAS UNWILLING TO PROVIDE THE PATIENT'S DATE OF DEATH, CAUSE OF DEATH, OR RELEVANT MEDICAL HISTORY.

    Additional Manufacturer Narrative · 0

    QN#(B)(4). 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.

    Description of Event or Problem · 0

    IT WAS REPORTED "THE INTRODUCER NEEDLE WAS NOT HARD ENOUGH TO INSERT SUBCLAVIAN VEIN". THE NEEDLE BENT TOWARDS THE LUNGS AND CAUSED A PNEUMOTHORAX. IT WAS REPORTED THE DEVICE WAS REPLACED. IT WAS UNKNOWN IF ANY TREATMENT WAS PROVIDED FOR THE PNEUMOTHORAX. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD DIED. THE PHYSICIAN REPORTED THE PNEUMOTHORAX WAS NOT THE CAUSE OF DEATH. THE PATIENT WAS WELL TREATED FOR, BUT OTHER CONDITIONS HAVE CAUSED THE DEATH. IT WAS REPORTED THE PNEUMOTHORAX HAD RESOLVED PRIOR TO THE PATIENT'S DEATH.

    Description of Event or Problem · 0

    IT WAS REPORTED "THE INTRODUCER NEEDLE WAS NOT HARD ENOUGH TO INSERT SUBCLAVIAN VEIN". THE NEEDLE BENT TOWARDS THE LUNGS AND CAUSED A PNEUMOTHORAX. IT WAS REPORTED THE DEVICE WAS REPLACED. IT WAS UNKNOWN IF ANY TREATMENT WAS PROVIDED FOR THE PNEUMOTHORAX. ADDITIONAL INFORMATION WAS RECEIVED THAT THE PATIENT HAD DIED. THE PHYSICIAN REPORTED THE PNEUMOTHORAX WAS NOT THE CAUSE OF DEATH. THE PATIENT WAS WELL TREATED FOR, BUT OTHER CONDITIONS HAVE CAUSED THE DEATH. IT WAS REPORTED THE PNEUMOTHORAX HAD RESOLVED PRIOR TO THE PATIENT'S DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2631044 ARROW CVC SET: 3-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL LLC 71F21F2450

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other