BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 20989298 · Received December 20, 2024

    Report

    Report Number
    3006425876-2024-01270
    Event Type
    Injury
    Date Received
    December 20, 2024
    Date of Event
    October 17, 2024
    Report Date
    December 3, 2024
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    UDI-DI
    00801902102324
    PMA / PMN Number
    K900263
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER
    Health Professional
    N

    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. CLINICAL AND MEDICAL AFFAIRS (CMA) WAS CONSULTED REGARDING THIS COMPLAINT. CMA STATED THAT THE ETIOLOGY OF FEVER IS MULTIFACTORIAL. DUE TO THE LIMITED INFORMATION PROVIDED REGARDING THE REPORTED INFECTION AND FEVER IN THE PATIENT, NO CAUSAL DETERMINATION CAN BE MADE AT THIS TIME. THE ROOT CAUSE FOR THE REPORTED EVENT IS UNDETERMINED. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Additional Manufacturer Narrative · 0

    (B)(4).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "DURING THE FIRST ATTEMPT TO INSERT THE GUIDEWIRE, THE GUIDEWIRE BECAME KINKED AND COULD NOT BE PULLED OUT FROM THE ARS. THE PHYSICIAN REMOVED THE ARS TOGETHER WITH THE NEEDLE AND THE GUIDEWIRE. ON THE SECOND ATTEMPT, A NEW GUIDEWIRE WAS USED, BUT THIS GUIDEWIRE WAS ALSO FOUND TO BE KINKED. THE GUIDEWIRE WAS REPLACED WITH A NEW ONE BUT WAS NOT SUCCESSFULLY PLACED. THIS GUIDEWIRE ISSUE CAUSED THE PATIENT TO UNDERGO REPEATED PUNCTURES OF THE CENTRAL VEIN, INCREASING THE RISK OF SIDE INJURY AND PRESENTING A SIGNIFICANT RISK OF THE GUIDEWIRE BREAKING INTO THE VESSEL. THE PATIENT SUBSEQUENTLY DEVELOPED AN INFECTION ASSOCIATED WITH THE PRODUCT BUT NO LONGER EXPERIENCED A FEVER AFTER THE CATHETER WAS REMOVED". THE PATIENT CONDITION IS FINE AND NO MEDICAL INTERVENTION WAS REQUIRED. THE ASSOCIATED EMDR NUMBERS ARE 3006425876-2024-01269, 3006425876-2024-01266, 3006425876-2024-01270.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: "DURING THE FIRST ATTEMPT TO INSERT THE GUIDEWIRE, THE GUIDEWIRE BECAME KINKED AND COULD NOT BE PULLED OUT FROM THE ARS. THE PHYSICIAN REMOVED THE ARS TOGETHER WITH THE NEEDLE AND THE GUIDEWIRE. ON THE SECOND ATTEMPT, A NEW GUIDEWIRE WAS USED, BUT THIS GUIDEWIRE WAS ALSO FOUND TO BE KINKED. THE GUIDEWIRE WAS REPLACED WITH A NEW ONE, BUT WAS NOT SUCCESSFULLY PLACED. THIS GUIDEWIRE ISSUE CAUSED THE PATIENT TO UNDERGO REPEATED PUNCTURES OF THE CENTRAL VEIN, INCREASING THE RISK OF SIDE INJURY AND PRESENTING A SIGNIFICANT RISK OF THE GUIDEWIRE BREAKING INTO THE VESSEL. THE PATIENT SUBSEQUENTLY DEVELOPED AN INFECTION ASSOCIATED WITH THE PRODUCT BUT NO LONGER EXPERIENCED A FEVER AFTER THE CATHETER WAS REMOVED". THE PATIENT CONDITION IS FINE AND NO MEDICAL INTERVENTION WAS REQUIRED. THE ASSOCIATED EMDR NUMBERS ARE 3006425876-2024-01269, 3006425876-2024-01266.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2164802 ARROW CVC SET: 3-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL LLC 71F23L0739 00801902102324

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown