BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VAXCEL PORT

    MDR report key: 5035588 · Received August 22, 2015

    Report

    Report Number
    MW5055768
    Event Type
    Injury
    Date Received
    August 22, 2015
    Date of Event
    August 18, 2015
    Report Date
    August 22, 2015
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJT
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    0

    Narratives

    Description of Event or Problem · 1

    RE: VAXCEL PORT, PRODUCT CODE: 45-310, LOT #4731897. MANUFACTURED BY: NAVILYST MEDICAL INC., (B)(4). TUBING FROM THIS PORT, USED FOR CHEMOTHERAPY, SEPARATED FROM THE PORT AND POTENTIALLY COULD HAVE MOVED THROUGH THE VEIN TO THE HEART. RESULTED IN REQUIREMENT FOR EMERGENCY SURGERY TO ACCESS VEIN FOR REMOVAL OF TUBE AND SUBSEQUENT SURGERY TO REMOVE AND REPLACE THE DEFECTIVE VAXCEL PORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    556642 VAXCEL PORT VAXCEL PORT LJT NAVILYST MEDICAL 45-310 4731897

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Hospitalization| L| R