BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UMBILI-CATH

    MDR report key: 18677307 · Received February 9, 2024

    Report

    Report Number
    1718873-2024-00001
    Event Type
    Injury
    Date Received
    February 9, 2024
    Date of Event
    January 18, 2024
    Report Date
    February 9, 2024
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC
    Product Code
    FOS
    UDI-DI
    H67142735050
    PMA / PMN Number
    K940953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    UTMD IS REPORTING THIS EVENT BECAUSE THE HOSPITAL STAFF STATED THAT A SUB XYPHOID SURGICAL RE-ENTRY WAS PERFORMED TO REMOVE THE REMAINING CATHETER FROM THE PATIENT. THE CT SURGERY ADVANCED LEAD AT THE USER FACILITY STATED THAT THE PATIENT IS DOING WELL. AFTER INVESTIGATION AT UTMD, THE RETURNED CATHETER HAD BEEN DAMAGED WITH SHARP INSTRUMENT AND THEN TORN. THE RETURNED CATHETER WAS PULL TESTED AT UTMD AND MET SPECIFICATIONS. THE IFU HAS CAUTIONS INDICATING TO TAKE CARE NOT TO DAMAGE THE SOFT SILICONE CATHETER DURING USE. (SEE IFU 57078 REV 022322).

    Description of Event or Problem · 0

    ON 1/18/2024, CATHETER BROKE DURING REMOVAL BY PHYSICIAN ASSISTANT. THE REMAINING CATHETER WAS REMOVED WITH SUB XYPHOID SURGICAL RE-ENTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1378497 UMBILI-CATH UMBILICAL CATHETER FOS UTAH MEDICAL PRODUCTS, INC 1230384 H67142735050

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention