BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARGYLE

    MDR report key: 19955246 · Received August 9, 2024

    Report

    Report Number
    1423537-2024-00106
    Event Type
    Injury
    Date Received
    August 9, 2024
    Report Date
    September 25, 2024
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    DRC
    UDI-DI
    10884521029309
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Additional Manufacturer Narrative · 0

    THE LOT NUMBER WAS PROVIDED, AND THE DEVICE HISTORY RECORD (DHR) WAS REVIEWED INDICATING THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. AS PART OF OUR MANUFACTURING PROCESS, ALL DEVICE HISTORY RECORDS ARE REVIEWED AND APPROVED BY QUALITY, PRIOR TO RELEASE OF PRODUCT. ONE (1) UNOPENED, UNUSED REPRESENTATIVE SAMPLE WAS RETURNED FOR EVALUATION. UPON VISUAL AND DIMENSIONAL INSPECTION, THE REPORTED ISSUE WAS NOT CONFIRMED, AND THE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE IDENTIFIED TO BE RELATED TO THE MANUFACTURING PROCESS. AT THIS TIME, A CORRECTIVE AND PREVENTIVE ACTION IS NOT DEEMED NECESSARY. WE WILL KEEP MONITORING THE PROCESS FOR ANY ADVERSE TRENDS THAT REQUIRE IMMEDIATE ATTENTION. THIS COMPLAINT WILL BE USED FOR QA TRACKING AND TRENDING PURPOSES.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT DURING THE END OF (B)(6) 2024, THE THORACIC CATHETER WAS KINKED AT THE POINT OF ENTRANCE, OR WAS KINKED INTRATHORACIC, AND WAS NOT FUNCTIONAL. THE PROCEDURE PERFORMED WAS A THORACIC PROCEDURE. THE PATIENT IS SAFE, BUT HOSPITALIZATION WAS PROLONGED. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT AT THE SECOND POSTOPERATIVE DAY, THE CHEST TUBE WAS SERIOUSLY KINKED AT THE POINT OF ENTRANCE. PER CUSTOMER, THE PATIENT WAS ALREADY HOSPITALIZED, AND THE HOSPITALIZATION WAS PROLONGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2174026 ARGYLE TROCAR DRC CARDINAL HEALTH, INC. 8888561068 19K137FHX 10884521029309

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Hospitalization