BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARROW SLIC COMPONENT: 7 FR X 8"

    MDR report key: 14836240 · Received June 27, 2022

    Report

    Report Number
    9680794-2022-00402
    Event Type
    Injury
    Date Received
    June 27, 2022
    Date of Event
    March 31, 2022
    Report Date
    June 9, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    KGZ
    UDI-DI
    10801902148091
    PMA / PMN Number
    K781846
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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 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 DEVICE HAD PERFORATED THE JUNCTION OF THE SUPERIOR VENA CAVA AND THE INNOMINATE VEIN. THIS WAS REPAIRED DURING THE SURGERY AND THE LINE WAS REMOVED. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE. CUSTOMER REPORTED THE ISSUE MAY HAVE BEEN RELATED TO USER ERROR.

    Description of Event or Problem · 0

    IT WAS REPORTED THE DEVICE HAD PERFORATED THE JUNCTION OF THE SUPERIOR VENA CAVA AND THE INNOMINATE VEIN. THIS WAS REPAIRED DURING THE SURGERY AND THE LINE WAS REMOVED. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE. CUSTOMER REPORTED THE ISSUE MAY HAVE BEEN RELATED TO USER ERROR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018574 ARROW SLIC COMPONENT: 7 FR X 8" ACCESSORIES, CATHETER KGZ ARROW INTERNATIONAL LLC IPN039999 14F19K0503 10801902148091

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention