BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CATHETER AND TIP, SUCTION

    MDR report key: 20054261 · Received August 23, 2024

    Report

    Report Number
    1423537-2024-00130
    Event Type
    Injury
    Date Received
    August 23, 2024
    Report Date
    August 23, 2024
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    JOL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS COMPLAINT WAS RECEIVED VIA AN ANONYMOUS CLINICAL STUDY. SAMPLE ANALYSIS COULD NOT BE PERFORMED SINCE SAMPLES WERE NOT PROVIDED FOR EVALUATION. THIS COMPLAINT WILL BE USED FOR TRENDING AND POST MARKET ANALYSIS.

    Description of Event or Problem · 0

    PER A POST MARKET CLINICAL SURVEY, THE CUSTOMER OBSERVED HEMOTHORAX WITH THE USE OF A CARDINAL ARGYLE THORACIC AND TROCAR CATHETER. THIS INFORMATION WAS RECEIVED VIA AN ANONYMOUS POST MARKET CLINICAL STUDY; THEREFORE, THE CUSTOMER INFORMATION IS UNKNOWN AND NO FURTHER INFORMATION WILL BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1363702 CATHETER AND TIP, SUCTION JOL CARDINAL HEALTH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other