BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL / VAXCEL

    MDR report key: 1193124 · Received October 7, 2008

    Report

    Report Number
    1317056-2008-00077
    Event Type
    Malfunction
    Date Received
    October 7, 2008
    Date of Event
    August 22, 2008
    Report Date
    September 11, 2008
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE INDICATED PACKAGING AND COMPONENT LOTS OF ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT WITH NO SUCH ISSUES BEING FOUND. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE USED DEVICE HAS BEEN RETURNED BY THE END USER HOSPITAL; HOWEVER, THE DEVICE ANALYSIS IS NOT YET COMPLETE. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. (B) (4).

    Description of Event or Problem · 1

    AS REPORTED, A 5F DUAL LUMEN PICC WAS PLACED ON (B) (6) 2008. ON (B) (6), A LEAK WAS NOTED WHERE THE CATHETER MEETS THE SUTURE WING, AND THE CATHETER WAS REMOVED AND REPLACED. NO SERIOUS INJURY WAS INCURRED BY THE PATIENT. THE USED DEVICE HAS BEEN RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST MEDICAL / VAXCEL DUAL LUMEN PICC LJS NAVILYST MEDICAL NA 1273489

    Patients

    Seq Age Sex Outcome Treatment
    1