BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB

    MDR report key: 15563196 · Received October 7, 2022

    Report

    Report Number
    9680794-2022-00652
    Event Type
    Injury
    Date Received
    October 7, 2022
    Date of Event
    July 21, 2022
    Report Date
    September 15, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    UDI-DI
    20801902117223
    PMA / PMN Number
    K071538
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). MEDWATCH REPORT # MW5111742.

    Additional Manufacturer Narrative · 0

    (B)(4). MEDWATCH REPORT # MW5111742. 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

    MEDWATCH RECEIVED REPORTS: "WHILE PLACING A RIGHT FEMORAL MML, DR. (B)(6) WAS REMOVING THE GUIDEWIRE, DR. (B)(6) STATED THAT SHE FELT THAT THE LINE BROKE. SHE REMOVED THE MML, AND GUIDEWIRE AND IT WAS DISCOVERED THAT THE GUIDEWIRE WAS FRAYED AND PARTIALLY CAME APART, POTENTIALLY BECOMING CATASTROPHIC TO THE PATIENT. DR. (B)(6) DECIDED TO DISCONTINUE THE LINE INSERTION. DR. (B)(6) HELD PRESSURE OVER THE INSERTION SITE TO STOP THE BLEEDING. DR. (B)(6) THEN DECIDED TO PLACE A DIFFERENT MML AT A DIFFERENT SITE. THE GUIDEWIRE AND PACKAGING FOR THE MML WAS SAVED FOR FURTHER INVESTIGATION."

    Description of Event or Problem · 0

    MEDWATCH RECEIVED REPORTS: "WHILE PLACING A RIGHT FEMORAL MML, DR. (B)(6) WAS REMOVING THE GUIDEWIRE, DR. (B)(6) STATED THAT SHE FELT THAT THE LINE ?BROKE?. SHE REMOVED THE MML, AND GUIDEWIRE AND IT WAS DISCOVERED THAT THE GUIDEWIRE WAS FRAYED AND PARTIALLY CAME APART, POTENTIALLY BECOMING CATASTROPHIC TO THE PATIENT. DR. (B)(6) DECIDED TO DISCONTINUE THE LINE INSERTION. DR. (B)(6) HELD PRESSURE OVER THE INSERTION SITE TO STOP THE BLEEDING. DR. (B)(6) THEN DECIDED TO PLACE A DIFFERENT MML AT A DIFFERENT SITE. THE GUIDEWIRE AND PACKAGING FOR THE MML WAS SAVED FOR FURTHER INVESTIGATION.".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2555879 ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB CATHETER,INTRAVASCULAR,THERAP FOZ ARROW INTERNATIONAL LLC IPN036482 13F22A0732 20801902117223

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other