BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DUAL LUMEN INSERTION TRAY

    MDR report key: 3842457 · Received February 20, 2014

    Report

    Report Number
    1317749-2014-00105
    Event Type
    Malfunction
    Date Received
    February 20, 2014
    Date of Event
    February 18, 2014
    Report Date
    February 19, 2014
    Manufacturer
    COVIDIEN
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    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) 2014 THAT A CUSTOMER HAD AN ISSUE WITH DUAL-LUMEN PERIPHERALLY INSERTED CENTRAL CATHETER (PICC). THE CUSTOMER REPORTS THE PICC LEAKED ABOUT 1CM BELOW THE BUTTERFLY. THE LEAK WAS UNDER THE TEGADERM DRESSING. THE CUSTOMER FURTHER REPORTS CHLORAPREP WAS USED TO CLEAN THE SKIN AREA AND THE AREA WAS COMPLETELY DRIED PRIOR TO INSERTION. IT WAS NOT DIFFICULT TO HANDLE THE CATHETER DURING INSERTION. IT WAS NOT DIFFICULT TO SECURE AND WAS SECURED WITH TEGADERM. THE PICC WAS INSERTED ON (B)(6) 2014 IN THE ARM. EACH LINE WAS FLUSHED ON A REGULAR BASIS WITH A 10CC SYRINGE. THE PICC WAS REMOVED ON (B)(6) 2014 AND WAS REPLACED WITH ANOTHER PICC LINE. THE STATUS OF THE PT IS GOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106590 DUAL LUMEN INSERTION TRAY PERIPHERALLY INSERTED CENTRAL CATH LJS COVIDIEN 43311 1320300060

    Patients

    Seq Age Sex Outcome Treatment
    1 14 DA