BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVILYST MEDICAL

    MDR report key: 1150477 · Received September 5, 2008

    Report

    Report Number
    1317056-2008-00063
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 8, 2008
    Manufacturer
    NAVILYST MEDICAL (FORMERLY NAMIC/VA)
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY REVIEW WAS PERFORMED ON THE REPORTED LOT NUMBER. THE REVIEW CONFIRMED THAT THE DEVICE COMPONENTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECS. NO PREVIOUS COMPLAINTS HAVE BEEN REC'D ON THE REPORTED LOT NUMBER. ALTHOUGH THE USED DEVICE WAS DISPOSED OF AT THE HOSP AND WILL NOT BE RETURNED FOR EVAL, AN INVESTIGATION IS BEING CONDUCTED. UPON COMPLETION OF OUR INVESTIGATION, A F/U MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    AS REPORTED, WHEN PLACING TO A PICC DEVICE, THE GUIDEWIRE WAS PLACED THROUGH THE NEEDLE, BUT WAS NOT ABLE TO BE ADVANCED. WHEN PULLED BACK, IT BEGAN TO UNRAVEL. THE PT WAS TAKEN TO RADIOLOGY TO REMOVE A SMALL PIECE OF GUIDEWIRE DETACHED FROM THE TIP. THERE WERE NO COMPLICATIONS TO THE PT. THE USED DEVICE HAS BEEN DISPOSED OF BY THE HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST MEDICAL VALVED PICC CATHETER LJS NAVILYST MEDICAL (FORMERLY NAMIC/VA) NA 1264776

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention