BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 14353400 · Received May 11, 2022

    Report

    Report Number
    9680794-2022-00278
    Event Type
    Death
    Date Received
    May 11, 2022
    Date of Event
    April 14, 2022
    Report Date
    April 14, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    PMA / PMN Number
    K071538
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 NO SAMPLE WAS RETURNED FOR ANALYSIS. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "ENSURE CATHETER PATENCY PRIOR TO INJECTION. DO NOT USE SYRINGES SMALLER THAN 10 ML (A FLUID FILLED 1 ML SYRINGE CAN EXCEED 300 PSI), TO MINIMIZE THE RISK OF INTRALUMINAL LEAKAGE OR CATHETER RUPTURE". THE IFU ALSO STATES, "DO NOT USE IF PACKAGE HAS BEEN PREVIOUSLY OPENED OR DAMAGED". 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. IF THE SAMPLE BECOMES AVAILABLE AT A LATER DATE A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CATHETER WAS NOT FLUSHING THROUGH ONE OF THE PORTS. THE PATIENT HAD REDNESS AT THE INSERTION SITE AND WHEN THE DRESSING WAS REMOVED IT WAS NOTICED THE REDNESS EXTENDED DOWN THE NECK. THE CATHETER WAS REMOVED. THE USER CUT THE TIP OFF THE CATHETER TO SEND FOR CULTURES AND MET A LOT OF RESISTANCE. ONCE IT WAS CUT, SOMETHING "WHITE AND PLASTIC LIKE" WAS INSIDE THE BROWN LUMEN OF THE CATHETER AND EXTENDED THROUGH THE ENTIRE LENGTH INSIDE THAT LUMEN. IT WAS REPORTED THE PATIENT WAS DECEASED AND THE CAUSE OF DEATH WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. NO INFORMATION WAS AVAILABLE REGARDING THE PATIENT'S CAUSE OF DEATH, DATE OF DEATH, OR MEDICAL HISTORY.

    Description of Event or Problem · 0

    IT WAS REPORTED THE CATHETER WAS NOT FLUSHING THROUGH ONE OF THE PORTS. THE PATIENT HAD REDNESS AT THE INSERTION SITE AND WHEN THE DRESSING WAS REMOVED IT WAS NOTICED THE REDNESS EXTENDED DOWN THE NECK. THE CATHETER WAS REMOVED. THE USER CUT THE TIP OFF THE CATHETER TO SEND FOR CULTURES AND MET A LOT OF RESISTANCE. ONCE IT WAS CUT, SOMETHING "WHITE AND PLASTIC LIKE" WAS INSIDE THE BROWN LUMEN OF THE CATHETER AND EXTENDED THROUGH THE ENTIRE LENGTH INSIDE THAT LUMEN. IT WAS REPORTED THE PATIENT WAS DECEASED AND THE CAUSE OF DEATH WAS UNKNOWN. ADDITIONAL INFORMATION WAS REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT. NO INFORMATION WAS AVAILABLE REGARDING THE PATIENT'S CAUSE OF DEATH, DATE OF DEATH, OR MEDICAL HISTORY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    693102 ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL LLC UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death NOT REPORTED.| NOT REPORTED.