BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVILYST MEDICAL (FORMERLY NAMIC/VA)

    MDR report key: 1150454 · Received September 5, 2008

    Report

    Report Number
    1317056-2008-00064
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 8, 2008
    Report Date
    August 8, 2008
    Manufacturer
    NAVILYST MEDICAL
    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 PACKAGING LOT. THE REVIEW CONFIRMED THAT THE DEVICE COMPONENTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. NO PREVIOUS COMPLAINTS HAVE BEEN RECEIVED ON THE REPORTED LOT. THE END USER HOSPITAL WOULD NOT RELEASE THE DEVICE FOR EVAL, HOWEVER, DID PROVIDE SEVERAL PHOTOGRAPHS OF THE DEVICE. THESE HAVE BEEN FORWARDED, ALONG WITH A SUPPLIER CORRECTIVE ACTION REQUEST TO OUR GUIDEWIRE, FOR THEIR REVIEW. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PICC PLACEMENT PROCEDURE, THE RESISTANCE WAS ENCOUNTERED WHEN ADVANCING THE GUIDEWIRE AND IT BEGAN TO "LOOP BACK UPON ITSELF." THE PT WAS SENT TO RADIOLOGY FOR REMOVAL OF THE WIRE. WHILE REMOVING IT, "IT BROKE ABOVE WHEN THE FLOPPY PART MEETS THE STIFFER PART." THE GUIDEWIRE WAS ABLE TO BE COMPLETELY REMOVED WITH NO PT COMPLICATIONS. THE DEVICE IS BEING RETAINED BY THE HOSPITAL, BUT PHOTOS AND AN X-RAY HAVE BEEN SENT FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST MEDICAL (FORMERLY NAMIC/VA) PICC CATHETER LJS NAVILYST MEDICAL NA 1272671

    Patients

    Seq Age Sex Outcome Treatment
    1