BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VYGON ECC CATHETER

    MDR report key: 1171583 · Received September 11, 2008

    Report

    Report Number
    1171583
    Event Type
    Malfunction
    Date Received
    September 11, 2008
    Date of Event
    July 22, 2008
    Report Date
    September 11, 2008
    Manufacturer
    VYGON CORPORATION
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ID, US

    Narratives

    Description of Event or Problem · 1

    PICC CATHETER DEVELOPED A HOLE NEAR THE HUB DURING PLACEMENT. THE NNP PLACING THE LINE WAS ABLE TO REPAIR THE CATHETER. THE MANUFACTURER RECOMMENDATION FOR SYRINGE SIZE WAS FOLLOWED (USED A 6ML SYRINGE FOR FLUSHING). A MONTH EARLIER, A PICC CATHETER DEVELOPED A HOLE AT THE 5CM MARK DURING PLACEMENT. THIS REQUIRED COMPLETE REMOVAL OF THE CATHETER AND PLACEMENT OF A NEW CATHETER IN A DIFFERENT VEIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VYGON ECC CATHETER CATHETER, PICC LJS VYGON CORPORATION * 029249
    2 * CATHETER, PICC LJS VYGON CORPORATION * 029249

    Patients

    Seq Age Sex Outcome Treatment
    1 6 DAY NO OTHER THERAPIES| NO OTHER THERAPIES