BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LIFECATH 1.9FR, PICC

    MDR report key: 2013521 · Received February 3, 2011

    Report

    Report Number
    2245270-2011-00008
    Event Type
    Malfunction
    Date Received
    February 3, 2011
    Date of Event
    November 30, 2011
    Report Date
    February 3, 2010
    Manufacturer
    VYGON
    Product Code
    LJS
    PMA / PMN Number
    K062425
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION OF THE COMPLAINT AND RETURNED DEVICE IS STILL PENDING. TEST METHOD, RESULTS AND CONCLUSIONS WILL BE PROVIDED IN A FOLLOW UP MDR.

    Description of Event or Problem · 1

    PERIPHERALLY INSERTED CATHETER WAS PLACED FOR 1 WEEK ON A NEWBORN WITH TPN INFUSION. THE CATHETER CAME APART WHERE IT MEETS THE WINGS. IT WAS RETRIEVED BEFORE MIGRATION OCCURRED. THERE WAS NO HARM OR BLOOD LOSS TO THE BABY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LIFECATH 1.9FR, PICC CATHETER, PICC LJS VYGON 2296.211 S0882

    Patients

    Seq Age Sex Outcome Treatment
    1