BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CARDINAL HEALTH

    MDR report key: 22386752 · Received July 2, 2025

    Report

    Report Number
    1423537-2025-00272
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    May 26, 2025
    Report Date
    August 25, 2025
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    KNT
    UDI-DI
    10884521518919
    PMA / PMN Number
    K833621
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATED THAT THE PRODUCT WAS RELEASED ACCOMPLISHING ALL QUALITY STANDARDS. PRIOR TO A LOT¿S RELEASE, THE LOT MUST BE DEEMED ACCEPTABLE BY PASSING INSPECTIONS THAT ARE BASED ON A VALID SAMPLING PLAN. DURING PRODUCTION, INSPECTORS ROUTINELY EXAMINE A STATISTICAL SAMPLE BOTH PHYSICALLY AND VISUALLY. THERE WERE NO SAMPLES RETURNED FOR EVALUATION; THEREFORE, THE AFFECTED DEVICE COULD NOT BE EVALUATED. AS SUCH, A ROOT CAUSE OF THE REPORTED CONDITION COULD NOT BE DETERMINED AT THIS TIME. WE WILL CONTINUE TO MONITOR RELATED REPORTS TO DETERMINE IF ADDITIONAL ACTIONS ARE NECESSARY.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT ENTRIFLEX PROBE MIGRATED TO THE LUNG SOON AFTER THE PROCEDURE, EVOLVING TO PNEUMOTHORAX AND IT WAS CONFIRMED THROUGH AN X-RAY IMAGE. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT APPROPRIATE INTERVENTIONS FOR THE PNEUMOTHORAX WERE PERFORMED. PER CUSTOMER, IT WAS NECESSARY TO PLACE A CHEST DRAIN WITH A WATER SEAL AND RECEIVE INTENSIVE CARE TO RESOLVE THE CLINICAL CONDITION. THE TREATMENTS WERE CARRIED OUT WITH GOOD RECOVERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7087 CARDINAL HEALTH TUBES, GASTROINTESTINAL (AND ACCESSORIES) KNT CARDINAL HEALTH, INC. 8884721252 2214502164 10884521518919

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other