BEUDAMED
    FDA Adverse Event Death Summary report: N

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

    MDR report key: 8850834 · Received August 1, 2019

    Report

    Report Number
    1036844-2019-00857
    Event Type
    Death
    Date Received
    August 1, 2019
    Date of Event
    July 16, 2019
    Report Date
    July 17, 2019
    Manufacturer
    ARROW INTERNATIONAL INC.
    Product Code
    LJS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. 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. 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

    COMPLAINT INFORMATION: WIRE WAS STUCK IN THE PATIENT AND MD WAS UNABLE TO RETRIEVE FROM PATIENT. UNSURE PATIENT CONDITION AT TIME OF PLACEMENT. THE REPORTED DEFECT WAS DETECTED DURING USE. THE PATIENT IS REPORTED TO BE DECEASED. THERAPY WAS REPORTED TO BE DELAYED/INTERRUPTED.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL INFORMATION RECEIVED FROM THE SALES REPRESENTATIVE INDICATING: THERE WAS NO SEPARATION OF THE WIRE, THE HOSPITAL REQUIRES ALL PRODUCTS TO BE LEFT IN THE PATIENT WHEN THERE IS A DEATH. THE DOCTOR DID NOT STATE THE DEATH WAS DUE TO THE WIRE.

    Description of Event or Problem · 1

    WIRE WAS STUCK IN THE PATIENT AND MEDICAL DOCTOR WAS UNABLE TO RETRIEVE FROM PATIENT. UNSURE PATIENT CONDITION AT TIME OF PLACEMENT. THE REPORTED DEFECT WAS DETECTED DURING USE. THE PATIENT IS REPORTED TO BE DECEASED. THERAPY WAS REPORTED TO BE DELAYED/INTERRUPTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    643653 ARROW PI CVC KIT: 3-L 7 FR X 20 CM AGB+ CATHETER, INTRAVASCULAR, THERAPEUTIC LJS ARROW INTERNATIONAL INC. 23F18L0186

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| O