BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5 FR. ARGYLE UMBILICAL VESSEL CATHETER

    MDR report key: 368734 · Received December 24, 2001

    Report

    Report Number
    MW1023673
    Event Type
    Injury
    Date Received
    December 24, 2001
    Date of Event
    May 8, 2001
    Report Date
    May 30, 2001
    Manufacturer
    SHERWOOD DAVIS & GECK SHERWOOD MEDICAL CO
    Product Code
    FOS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PR, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IN 2001, A PT WITH DIAGNOSIS OF BILATERAL PNEUMONIA, PULMONARY HYPERTENSION AND PNEUMOTHORAX IN RIGHT LUNG, PRESENTED PERIFEROVASCULAR CHANGES IN ABDOMEN, BACK IN LOWER EXTREMITIES. ACCORDING TO THESE SYMPTOMS, IT WAS PROCEDED TO REMOVE THE UMBILICAL CATHETER. DURING THE PROCEDURE THE UMBILICAL CATHETER BROKE LEAVING PART OF THE CATHETER INSIDE OF THE UMBILICAL ARTERY OF THE PT. BECAUSE OF THIS, THE PT HAD TO BE TRANSFERRED TO A CARDIOVASCULAR CENTER 2 DAYS LATER, FOR EXTRACTION OF THE LINE. PT RETURNS AT THIS HOSP 5 DAYS LATER, TO CONTINUE TREATMENT. PT WAS DISCHARGED 10 DAYS LATER, IN STABLE CONDITION. DEVICE AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58382 3.5 FR. ARGYLE UMBILICAL VESSEL CATHETER CATHETER FOS SHERWOOD DAVIS & GECK SHERWOOD MEDICAL CO ARGYLE 405866

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DAY Hospitalization| L| R NASOGASTRIC TUBE - 2001, UMBILICAL CATHETER 2001.