BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UMBILI-CATH

    MDR report key: 16987272 · Received May 23, 2023

    Report

    Report Number
    1718873-2023-00001
    Event Type
    Injury
    Date Received
    May 23, 2023
    Date of Event
    May 6, 2023
    Report Date
    May 23, 2023
    Manufacturer
    UTAH MEDICAL PRODUCTS, INC
    Product Code
    FOS
    UDI-DI
    H67142735050
    PMA / PMN Number
    K940953
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UTMD IS REPORTING THIS EVENT BECAUSE THE HOSPITAL STAFF STATED THAT A INTERVENTIONAL RADIOLOGY WAS PERFORMED TO REMOVE THE REMAINING CATHETER FROM THE PATIENT. THE MGR NICU PEDS AT USER FACILITY STATED THAT THE PATIENT WAS STABLE AND THERE WAS NO KNOWN LONG TERM EFFECTS TO THE PATIENT. 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 TUBING DURING USE. (SEE IFU 58078 REV 022322).

    Description of Event or Problem · 0

    ON (B)(6) 2023. THE CATHETER BROKE DURING REMOVAL. THE REMAINING PIECE REMAINED INTERNAL AND THE INFANT SUBSEQUENTLY HAD TO BE SHIPPED TO THE HIGHER LEVEL OF CARE FOR REMOVAL. THE REMAINING CATHETER WAS REMOVED AT ANOTHER FACILITY WITH INTERVENTIONAL RADIOLOGY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244581 UMBILI-CATH UMBILICAL CATHETER FOS UTAH MEDICAL PRODUCTS, INC Dual-Lumen Silicone 1223017 H67142735050

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA Unknown Required Intervention