BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW MULTILUMEN/PSI KIT 9 FR X 11.5 CM

    MDR report key: 17914551 · Received October 11, 2023

    Report

    Report Number
    9680794-2023-00786
    Event Type
    Malfunction
    Date Received
    October 11, 2023
    Date of Event
    August 12, 2023
    Report Date
    September 14, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    UDI-DI
    10801902112054
    PMA / PMN Number
    K011761
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    QN# (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, "THE PRACTITIONER MUST BE AWARE OF POTENTIAL AIR EMBOLISM ASSOCIATED WITH LEAVING OPEN NEEDLES, SHEATHS, OR CATHETERS IN VENOUS PUNCTURE SITES OR AS A CONSEQUENCE OF INADVERTENT DISCONNECTS. TO LESSEN THE RISK OF DISCONNECTS, ONLY SECURELY TIGHTENED LUER-LOCK CONNECTIONS SHOULD BE USED WITH THIS DEVICE. FOLLOW HOSPITAL PROTOCOL FOR ALL SHEATH AND SIDE PORT MAINTENANCE". THE IFU ALSO STATES, "DO NOT SUTURE DIRECTLY TO THE OUTSIDE DIAMETER OF ACCESS DEVICE TO MINIMIZE THE RISK OF CUTTING OR DAMAGING DEVICE OR IMPEDING DEVICE FLOW". A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON A POTENTIAL LOT FROM SALES HISTORY, 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.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    MEDWATCH FORM RECEIVED REPORTS: "LIJ INTRODUCER WITH CLIP IN TRIPLE CVC PLACED VIA US GUIDED WITH TEE AND REMOVED NEXT DAY. AIR IN WHITE LUMEN WHEN PULLED BACK WITH SYRINGE. CNS HAS LINE. LEAKING."

    Description of Event or Problem · 0

    MEDWATCH FORM RECEIVED REPORTS: "LIJ INTRODUCER WITH CLIP IN TRIPLE CVC PLACED VIA US GUIDED WITH TEE AND REMOVED NEXT DAY. AIR IN WHITE LUMEN WHEN PULLED BACK WITH SYRINGE. CNS HAS LINE. LEAKING."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2067753 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 NOT REPORTED.| NOT REPORTED.