BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 2-LUMEN 7 FR X 20 CM

    MDR report key: 17441684 · Received August 2, 2023

    Report

    Report Number
    3006425876-2023-00716
    Event Type
    Malfunction
    Date Received
    August 2, 2023
    Date of Event
    July 7, 2023
    Report Date
    July 10, 2023
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    UDI-DI
    00801902102362
    PMA / PMN Number
    K900263
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    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 NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND FOR MATERIAL EBZ-27702-002, A NON-CONFORMANCE WAS INITIATED FOR LOT 72C21M0373 TO ADDRESS THE ISSUE OF "HIGH SCRAP RATE". WITHOUT THE SAMPLE RETURNED FOR EVALUATION, IT CANNOT BE CONFIRMED IF THE NON-CONFORMANCE IS RELATED TO THE CUSTOMER REPORT. 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

    IT WAS REPORTED THE PHYSICIAN FELT MORE RESISTANCE THAN USUAL WHEN PUSHING SALINE THROUGH THE CATHETER PRIOR TO INSERTION. THE CATHETER WAS INSERTED INTO THE PATIENT AND THE SAME DAY "THE DOCTOR STILL FEEL THE RESISTANCE WHEN THEY USE THE SYRINGE PUSH SALINE AND PUMPING BACK TO THE BLOOD". ON THE 10TH OF JULY THE NURSES REPORT "THE RESISTANCE BECOMES SMALLER, BACK TO NORMAL". NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE PHYSICIAN FELT MORE RESISTANCE THAN USUAL WHEN PUSHING SALINE THROUGH THE CATHETER PRIOR TO INSERTION. THE CATHETER WAS INSERTED INTO THE PATIENT AND THE SAME DAY "THE DOCTOR STILL FEEL THE RESISTANCE WHEN THEY USE THE SYRINGE PUSH SALINE AND PUMPING BACK TO THE BLOOD". ON THE 10TH OF JULY THE NURSES REPORT "THE RESISTANCE BECOMES SMALLER, BACK TO NORMAL". NO PATIENT HARM WAS REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1384991 ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER INTRAVASCULAR THERAPE FOZ ARROW INTERNATIONAL LLC 71F22J2432 00801902102362

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown NOT REPORTED| NOT REPORTED