BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVILYST MEDICAL / BIOFLO

    MDR report key: 3030761 · Received March 27, 2013

    Report

    Report Number
    1317056-2013-00012
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    December 23, 2012
    Report Date
    February 26, 2013
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJS
    PMA / PMN Number
    K121089
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH NO USED DEVICES ARE BEING RETURNED TO NAVILYST MEDICAL FOR EVALUATION, THE INVESTIGATION INTO THIS EVENT IS STILL ON-GOING, WITH ADDITIONAL INFORMATION EXPECTED TO BE RECEIVED FROM THE END USER HOSPITAL. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    HOSPITAL REPORTS A PT DEVELOPING A DVT WHILE THE NAVILYST BIOFLO 6F TRIPLE LUMEN PICC WAS IN PLACE. THE PICC WAS LOCATED IN THE RIGHT BASILIC. THE DCT WAS VERIFIED VIA DOPPLER. THE PT WAS TREATED FOR THE DVT WITH NO FURTHER COMPLICATIONS OR INJURIES. FURTHER EVENT DETAILS ARE NOT AVAILABLE AT THIS TIME. THE HOSPITAL HAS BEEN CONTACTED AND HAS BEEN REQUESTED TO PROVIDE ADDITIONAL INFORMATION TO NAVILYST MEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126190 NAVILYST MEDICAL / BIOFLO CATHETER, INTRAVASCULAR, THERAPEUTIC LJS NAVILYST MEDICAL NA 4482169D

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention