BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VAXCEL PASV PICC / NAMIC/VA

    MDR report key: 2823595 · Received August 18, 2008

    Report

    Report Number
    1317056-2008-00060
    Event Type
    Malfunction
    Date Received
    August 18, 2008
    Date of Event
    June 17, 2008
    Report Date
    July 23, 2008
    Manufacturer
    NAMIC/VA
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORDS FOR THE REPORTED LOT NUMBER WAS PERFORMED FOR ANY DEVIATIONS RELATED TO THE REPORTED DEFECT OF THE COMPLAINT. THE REVIEW CONFIRMS THAT THE LOTS MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. A REVIEW OF THE JUNE 2008 NAMIC/VA COMPLAINT REPORT FOR THE VAXCEL PASV PICC PRODUCT FAMILY DID NOT NOTE ANY ADVERSE TRENDS ASSOCIATED WITH THE REPORTED FAILURE MODE. ALTHOUGH THE USED DEVICE HAS BEEN RETURNED FOR EVALUATION, THE DEVICE ANALYSIS HAS NOT YET BEEN COMPLETED. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    DURING A PT PROCEDURE, LEAKAGE OCCURRED FROM THE VALVED PICC DEVICE AT A LOCATION DISTAL TO THE SUTURE WING. THERE WAS NO REPORT OF PT COMPLICATIONS. THE USED DEVICE HAS BEEN RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 VAXCEL PASV PICC / NAMIC/VA VALVED PICC LJS NAMIC/VA NA 1262119

    Patients

    Seq Age Sex Outcome Treatment
    1