BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGYLE

    MDR report key: 16183520 · Received January 17, 2023

    Report

    Report Number
    16183520
    Event Type
    Malfunction
    Date Received
    January 17, 2023
    Date of Event
    January 4, 2023
    Report Date
    January 12, 2023
    Manufacturer
    CARDINAL HEALTH 200, LLC
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    NURSE WAS ASSESSING PATIENT AND NOTICED A SMALL DROP OF FLUID LEAK ON TO PATIENT'S ABDOMEN. UPON FURTHER ASSESSMENT, IT WAS NOTED THE PATIENT'S PERIPHERALLY INSERTED CENTRAL CATHETER (PICC) LINE IN THE RIGHT ACCESSORY CEPHALIC VEIN HAD A SMALL LEAK FROM THE LINE AS IF THERE WAS A CRACK IN THE LINE. CHARGE NURSE WAS NOTIFIED TO COME ASSESS AND NEONATAL NURSE PRACTITIONER (NNP) WAS CALLED. NNP ORDERED PICC LINE TO BE REMOVED. CHARGE NURSE REMOVED THE LINE, STARTED A PERIPHERAL INTRAVENOUS LINE (PIV), AND RESTARTED FLUIDS, 1X DOSE OF VANCOMYCIN GIVEN PER NNP ORDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426314 ARGYLE CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS LJS CARDINAL HEALTH 200, LLC 43303 1930300072

    Patients

    Seq Age Sex Outcome Treatment
    1 7 DA Female