BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTEC TITANIUM PORT-A-CATH, LOW PROFILE

    MDR report key: 24654472 · Received March 20, 2026

    Report

    Report Number
    3012307300-2026-02769
    Event Type
    Injury
    Date Received
    March 20, 2026
    Date of Event
    February 5, 2026
    Report Date
    May 27, 2026
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    LJT
    PMA / PMN Number
    UNKNOWN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D4: LIST NUMBER 21-4053-24 OR 21-4083-24. H6: INVESTIGATION INCLUDING ROOT CAUSE ANALYSIS IS IN PROGRESS. A SUPPLEMENTAL MDR WILL BE FILED AS NECESSARY IN ACCORDANCE WITH 21 CFR 803.56 WHEN ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 0

    THE SUSPECTED DEVICE AND PHOTOS WERE RETURNED FOR EVALUATION. VISUAL INSPECTION IDENTIFIED THE CATHETER RETURNED IN TWO SEGMENTS WITH ONE FRAYED END, WHILE REMAINING CONNECTED TO THE PORT WITH THE CATH-LOCK ENGAGED. NO ADDITIONAL DAMAGE OR ANOMALIES WERE OBSERVED. FUNCTIONAL TESTING CONFIRMED FREE FLOW WITH NO LEAKS. THE COMPLAINT OF CATHETER BREAKAGE WAS CONFIRMED. BASED ON THE IFU REVIEW AND EVALUATION FINDINGS, THE PROBABLE CAUSE WAS DETERMINED TO BE INCORRECT CATHETER PLACEMENT OR IMPLANTATION. A RETROSPECTIVE REVIEW IDENTIFIED NO RELATED COMPLAINTS OR NONCONFORMITIES FOR THE REPORTED LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, DURING A FOLLOW-UP EXAMINATION OF THE PATIENT'S PERISPLENIC ABSCESS, THE RADIOLOGIST NOTICED A DETACHED CATHETER FRAGMENT FROM THE PORT-A-CATH DEVICE LOCATED IN THE RIGHT VENTRICLE. PER REPORTER, THE CATHETER WAS REMOVED ON (B)(6) 2026 AND THE PORT WAS REMOVED ON (B)(6) 2026. THE PROCEDURE WAS PERFORMED ON AN OUTPATIENT BASIS AND WAS WITHOUT ANY COMPLICATIONS. THERE WERE NO ADVERSE EFFECTS OR SYMPTOMS REPORTED AS A RESULT OF THE REMAINING FRAGMENT AND FOLLOWING THE PORT REMOVAL THE PATIENT IS REPORTED TO BE DOING WELL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232922 DELTEC TITANIUM PORT-A-CATH, LOW PROFILE PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT ICU MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1