BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FLOCATH QUICK HYDROPHILIC

    MDR report key: 16777866 · Received April 20, 2023

    Report

    Report Number
    8040412-2023-00170
    Event Type
    Malfunction
    Date Received
    April 20, 2023
    Date of Event
    April 3, 2023
    Report Date
    April 4, 2023
    Manufacturer
    TELEFLEX MEDICAL SDN. BHD.
    Product Code
    GBM
    UDI-DI
    04026704323883
    PMA / PMN Number
    K183461
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). 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. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Additional Manufacturer Narrative · 0

    (B)(4). N/A. OTHER REMARKS: N/A. CORRECTED DATA: N/A.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT PACKAGING WAS OPEN AT THE BOTTOM. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS ANSWERED OUR INQUIRIES BUT STATES THAT THERE IS NO OTHER INFORMATION AVAILABLE. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED. SEE ASSOCIATED MDRS 8040412-2023-00134, 8040412-2023-00169, 8040412-2023-00168, 8040412-2023-00167, 8040412-2023-00166, 8040412-2023-00165, 8040412-2023-00164, 8040412-2023-00163, 8040412-2023-00162, 8040412-2023-00161, 8040412-2023-00160, 8040412-2023-00159, 8040412-202 3-00158, 8040412-2023-00176, 8040412-2023-00175, 8040412-2023-00174, 8040412-2023-00173, 8040412-2023-00172, AND 8040412-2023-00171.

    Description of Event or Problem · 0

    THE PATIENT REPORTED THAT PACKAGING WAS OPEN AT THE BOTTOM. AT THE TIME OF THIS REPORT, THE CUSTOMER HAS ANSWERED OUR INQUIRIES BUT STATES THAT THERE IS NO OTHER INFORMATION AVAILABLE. THE COMPLAINT FILE WILL BE UPDATED IF FURTHER INFORMATION IS RECEIVED. SEE ASSOCIATED MDRS 8040412-2023-00134, 8040412-2023-00169, 8040412-2023-00168, 8040412-2023-00167, 8040412-2023-00166, 8040412-2023-00165, 8040412-2023-00164, 8040412-2023-00163, 8040412-2023-00162, 8040412-2023-00161, 8040412-2023-00160, 8040412-2023-00159, 8040412-202 3-00158, 8040412-2023-00176, 8040412-2023-00175, 8040412-2023-00174, 8040412-2023-00173, 8040412-2023-00172, 8040412-2023-00171.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1155692 FLOCATH QUICK HYDROPHILIC CATHETER, URETHRAL GBM TELEFLEX MEDICAL SDN. BHD. IPN050863 KME22D0529 04026704323883

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown