BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5FR DUAL-LUMEN UVC CATH

    MDR report key: 2883809 · Received November 16, 2012

    Report

    Report Number
    1317749-2012-00287
    Event Type
    Malfunction
    Date Received
    November 16, 2012
    Date of Event
    September 30, 2012
    Report Date
    October 23, 2012
    Manufacturer
    COVIDIEN
    Product Code
    FOS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SUBMIT DATE (B)(6) 2012. AN INVESTIGATION IS CURRENTLY UNDERWAY. UPON COMPLETION, THE RESULTS WILL BE FORWARDED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO COVIDIEN ON (B)(6) 2012 THAT A CUSTOMER HAD AN ISSUE WITH AN UMBILICAL VESSEL CATHETER UVC). THE CUSTOMER REPORTED THAT THE UVC WAS LEAKING AT THE HUB. THE CATHETER WAS PLACED ON (B)(6) 2012. IT WAS REPORTED THAT THE CATHETER FELT STIFFER THAN USUAL ON PLACEMENT. THE CUSTOMER NOTED THE CATHETER LEAKING ON (B)(6) 2012. APPROXIMATELY 3MLS. OF BLOOD WAS LOST AS REPORTED BY THE CUSTOMER. THE NEONATAL NURSE PRACTITIONER (NNP) WAS NOTIFIED AND ORDERS WERE RECEIVED TO DISCONNECT THE LINE. PT WAS STABLE AND WEANING OFF THE VENT AFTER INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 3.5FR DUAL-LUMEN UVC CATH UVC FOS COVIDIEN 8888160531 60932

    Patients

    Seq Age Sex Outcome Treatment
    1 5 DA