BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 3-LUMEN 7 FR X 20 CM

    MDR report key: 15666639 · Received October 25, 2022

    Report

    Report Number
    3006425876-2022-00900
    Event Type
    Malfunction
    Date Received
    October 25, 2022
    Date of Event
    September 30, 2022
    Report Date
    September 30, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). ASSOCIATED MDR#S FOR KINKED GUIDWIRE: 3006425876-2022-00902; 3006425876-2022-00901; 3006425876-2022-00900; 3006425876-2022-00899. 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.

    Additional Manufacturer Narrative · 0

    QN#(B)(4). ASSOCIATED MDR#S FOR KINKED GUIDWIRE: 3006425876-2022-00902; 3006425876-2022-00901; 3006425876-2022-00899.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: THE FIRST, SECOND AND THIRD SPRING WIRE GUIDES WERE UNABLE TO BE REMOVED DUE TO THE WIRE KINKING WHEN USED ON THE RIGHT NECK. THE FOURTH SPRING WIRE GUIDE WAS UNABLE TO BE REMOVED DUE TO WIRE STUCK WITH ARS (ARROW RAULERSON SYRINGE) WHEN USED ON THE RIGHT FEMUR (NO KINKING OF WIRE REPORTED). THE FIFTH SPRING WIRE GUIDE WAS UNABLE TO BE REMOVED DUE TO WIRE KINKING WHEN USED ON THE LEFT NECK. THE SIXTH SPRING WIRE GUIDE WAS SUCCESSFULLY INSERTED IN THE PATIENT. NO PATIENT HARM OR INJURY WAS REPORTED. NO DELAY IN THERAPY. A NEW DEVICE WAS USED. NO ADDITIONAL MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Description of Event or Problem · 0

    THE COMPLAINT IS REPORTED AS: THE FIRST, SECOND AND THIRD SPRING WIRE GUIDES WERE UNABLE TO BE REMOVED DUE TO THE WIRE KINKING WHEN USED ON THE RIGHT NECK. THE FOURTH SPRING WIRE GUIDE WAS UNABLE TO BE REMOVED DUE TO WIRE STUCK WITH ARS (ARROW RAULERSON SYRINGE) WHEN USED ON THE RIGHT FEMUR (NO KINKING OF WIRE REPORTED). THE FIFTH SPRING WIRE GUIDE WAS UNABLE TO BE REMOVED DUE TO WIRE KINKING WHEN USED ON THE LEFT NECK. THE SIXTH SPRING WIRE GUIDE WAS SUCCESSFULLY INSERTED IN THE PATIENT. NO PATIENT HARM OR INJURY WAS REPORTED. NO DELAY IN THERAPY. A NEW DEVICE WAS USED. NO ADDITIONAL MEDICAL INTERVENTION REQUIRED. THE PATIENT'S CONDITION WAS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2665176 ARROW CVC SET: 3-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL LLC 71F22B1718

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown