BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 14380178 · Received May 12, 2022

    Report

    Report Number
    3006425876-2022-00449
    Event Type
    Malfunction
    Date Received
    May 12, 2022
    Date of Event
    April 21, 2022
    Report Date
    April 21, 2022
    Manufacturer
    ARROW INTERNATIONAL LLC
    Product Code
    DQY
    PMA / PMN Number
    K862056
    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). THE ACTUAL DEVICE WAS NOT RETURNED; HOWEVER, THE CUSTOMER PROVIDED ONE PHOTO FOR ANALYSIS. THE COMPLAINT OF SYRINGE LEAK IN USE CANNOT BE CONFIRMED BY THE PHOTO AS THERE IS NO VISUAL EVIDENCE OF THE SYRINGE LEAKING. A COMPLETE VISUAL INSPECTION 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 71P21G0463 IN REGARDS TO "SYRINGE/NEEDLE CONNECTION NOT SECURE". HOWEVER, WITHOUT THE DEVICE TO EVALUATE, IT CANNOT BE CONFIRMED IF THIS ISSUE IS LINKED WITH THE FAILURE MODE INVOLVED WITH THIS COMPLAINT. 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 PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.

    Description of Event or Problem · 0

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

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789646 ARROW CVC SET: 2-LUMEN 7 FR X 20 CM CATHETER PERCUTANEOUS DQY ARROW INTERNATIONAL LLC 71F21J0378

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown