BEUDAMED
    FDA Adverse Event Death Summary report: N

    ARGYLE

    MDR report key: 21160650 · Received January 15, 2025

    Report

    Report Number
    1423537-2025-00033
    Event Type
    Death
    Date Received
    January 15, 2025
    Date of Event
    June 25, 2024
    Report Date
    January 31, 2025
    Manufacturer
    CARDINAL HEALTH, INC.
    Product Code
    JOL
    UDI-DI
    10884521050846
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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 DEVICE HISTORY RECORD FOR LOT 2327900464 WAS REVIEWED AND NO ANOMALIES RELATED TO THE REPORTED ISSUE WERE OBSERVED. THE DEVICE WAS MANUFACTURED ON OCTOBER 10, 2023. THERE WERE NO PHOTOS OR PHYSICAL SAMPLES RECEIVED FOR EVALUATION. BECAUSE A SAMPLE WAS NOT RETURNED, WE WERE UNABLE TO PERFORM A FOLLOW UP INVESTIGATION TO INCLUDE FUNCTIONAL AND VISUAL EVALUATIONS TO CONFIRM THE ISSUE AND ROOT CAUSE ANALYSIS. BASED ON THIS INFORMATION, NO CORRECTIVE ACTIONS ARE WARRANTED AT THIS TIME. WE WILL CONTINUE TO TRACK AND TREND THROUGH OUR MONITORING PROGRAMS AND TAKE ACTIONS AS APPLICABLE.

    Additional Manufacturer Narrative · 0

    SECTION D4 (MODEL NUMBER AND CATALOG NUMBER): ORIGINALLY REPORTED AS 8888571042 AND SHOULD BE 8888570549. SECTION G3/G4 (PMA/510(K)NUMBER): ORIGINALLY REPORTED AS E223935 AND SHOULD BE EXEMPT.

    Description of Event or Problem · 0

    THE CUSTOMER REPORTED THAT THERE WAS A PARTIAL DISLODGE OF CHEST TUBE WITH EXPOSED EYELET AND SUTURE FELL OFF. NO UNUSUAL CIRCUMSTANCES NOTED. THE CLINICAL STAFF NOTICED WORSENING AIR LEAK AND INFORMED THE TEAM. THE NURSE PRACTITIONER (NP) AND SURGEON CAME TO ASSESS AND DISCOVERED PARTIAL DISLODGE. THE CHEST TUBE WAS REMOVED. THE PATIENT DETERIORATED OVER THE NEXT FEW DAYS, TRANSFERRED TO ICU AND INTUBATED. THIS WAS MOST LIKELY DUE TO UNDERLYING CLINICAL FACTORS, BUT THE CHEST TUBE DISLODGES LIKELY CONTRIBUTED TO DETERIORATION AS WELL (<50%). IT IS VERY UNUSUAL TO HAVE A PARTIAL DISLODGE WITH EYELET EXPOSURE, SO THEY HAD TO PROVIDE ADDITIONAL STAFF EDUCATION AND UPDATE THEIR POLICY TO INCLUDE THIS SITUATION. PER CUSTOMER, THE CHEST TUBE WAS IN FOR 5 DAYS. ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER AND STATED THAT THERE WAS NO DETACHMENT, SPLITS OR BREAKS. DUE TO THE TUBE BEING VERY RIGID AND DIFFICULT TO SUTURE TO THE CHEST WALL, AN EYELET THAT SHOULD HAVE BEEN BELOW THE DERMIS IN THE CHEST WALL TO FACILITATE DRAINAGE WAS EXPOSED. THE PATIENT HAD MULTIPLE COMORBIDITIES; DETERIORATION NOT LIKELY DUE TO THE PARTIAL DISLODGE. PATIENT DETERIORATION WAS ATTRIBUTED TO PATIENT SEDATION AND RESPIRATORY ACIDOSIS. THE PATIENT WAS INTERMITTENTLY CONFUSED AND REFUSING HIGH FLOW NON-REBREATHER MASK, BIPAP AND OPTIFLOW WITH RT. THE PATIENT DIED IN ICU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1274446 ARGYLE CATHETER AND TIP, SUCTION JOL CARDINAL HEALTH, INC. 8888570549 2327900464 10884521050846

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Death