BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARROW CVC SET: 16 GA X 8" (20 CM)

    MDR report key: 14349592 · Received May 10, 2022

    Report

    Report Number
    3006425876-2022-00395
    Event Type
    Malfunction
    Date Received
    May 10, 2022
    Date of Event
    January 27, 2022
    Report Date
    April 18, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    FOZ
    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 WITH ONE RELEVANT FINDING. A NON-CONFORMANCE WAS INITIATED FOR MATERIAL K-04300-019A, LOT 71P21B0956, IN REGARD TO "SYRINGE/NEEDLE CONNECTION NOT SECURE IN USE". THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT WARNS THE USER, "WARNING: DO NOT ASPIRATE ARROW RAULERSON SYRINGE WHILE GUIDEWIRE IS IN PLACE; AIR MAY ENTER SYRINGE THROUGH REAR VALVE. PRECAUTION: DO NOT REINFUSE BLOOD TO REDUCE RISK OF BLOOD LEAKAGE FROM REAR (CAP) OF SYRINGE." 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 ARS (ARROW RAULERSON SYRINGE) WAS FOUND LEAKING DURING USE ON THE PATIENT. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Description of Event or Problem · 0

    IT WAS REPORTED THE ARS (ARROW RAULERSON SYRINGE) WAS FOUND LEAKING DURING USE ON THE PATIENT. NO PATIENT HARM REPORTED. THE PATIENT'S CONDITION IS REPORTED AS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    871903 ARROW CVC SET: 16 GA X 8" (20 CM) CATHETER,INTRAVASCULAR,THERAP FOZ ARROW INTERNATIONAL LLC 71F21E2412

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown