BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARGYLE 3.5 FR SINGLE LUMEN

    MDR report key: 3831902 · Received April 18, 2014

    Report

    Report Number
    3831902
    Event Type
    Malfunction
    Date Received
    April 18, 2014
    Date of Event
    March 17, 2014
    Report Date
    April 18, 2014
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE COMPLAINT FROM OUR STAFF STATED THAT THE UAC CATHETER WAS NOTED TO BE LEAKING IVF FLUIDS FROM AND BLOOD WAS BACKING UP INTO THE CATHETER. THE FOLLOWING IS A REVIEW FINDING RELATED TO THIS INCIDENT REPORTED BY STAFF. A 3.5 FRENCH SINGLE LUMEN UAC LEAK AT HUB CONNECTOR/ LINE CONNECTION AREA. THE LINE WAS IN PLACE FOR 5 DAYS EARLIER THIS YEAR. THE PACKAGING WAS NOT RETAINED. THERE IS NO LOT NUMBER AVAILABLE. THE TRANSDUCER WAS CHANGED ON NIGHT OF LEAK APPROXIMATELY 2-3 HOURS PRIOR; HOWEVER WAS NOT CLAMPED NEAR THE HUB CONNECTOR. THE TRANSDUCER CHANGE WOULD THEREFORE NOT BE A CAUSE FOR THE LEAK. THE REVIEWER BELIEVED THAT THIS LEAK DID WARRANT REPORTING TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    238541 ARGYLE 3.5 FR SINGLE LUMEN CATHETER, UMBILICAL ARTERY FOS COVIDIEN * *

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DAY