BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST MEDICAL

    MDR report key: 4161833 · Received July 24, 2014

    Report

    Report Number
    1317056-2014-00049
    Event Type
    Malfunction
    Date Received
    July 24, 2014
    Date of Event
    June 25, 2014
    Report Date
    July 1, 2014
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJT
    PMA / PMN Number
    UNK
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    FROM THE INFORMATION PROVIDED BY THE REHABILITATION CENTER WHICH REPORTED THE EVENT, IT IS NOT POSSIBLE TO CONFIRM NEITHER THE CATALOG NUMBER OF THE PORT, OR IF THE PORT WAS MANUFACTURED BY NAVILYST MEDICAL. IT WAS INDICATED THAT THE PORT WAS RETURNED THE WEEK OF (B)(4), HOWEVER, IT HAS NOT BEEN RECEIVED AT ANY OF THE NAVILYST MEDICAL/ANGIODYNAMICS FACILITIES, THEREFORE CONFIRMING THE MANUFACTURER OF THE DEVICE AND/OR A DEVICE EVALUATION HAS NOT BEEN POSSIBLE. WHEN FOLLOWING UP ON THE SHIPPING STATUS OF THE SAMPLE, IT WAS AGAIN STATED BY THE EVENT REPORTER THAT THE PATIENT'S HEALTH WAS NOT ADVERSELY AFFECTED BY THE EVENT. SHOULD THE SAMPLE BE RECEIVED AND BE IDENTIFIED AS HAVING BEEN MANUFACTURED BY NAVILYST MEDICAL, THIS COMPLAINT WILL BE RE-OPENED, (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY A REHABILITATION CENTER (NOT A CUSTOMER OF NAVILYST MEDICAL/ANGIODYNAMICS): A PATIENT CAME IN VIA TRANSPORT, AND WAS NOTED TO HAVE PORT WHICH WAS "LEAKING OUTSIDE THE BODY WHEN IT WAS BEING ACCESSED. IT WAS REMOVED AND REPLACED". WITH A PORT FROM THE REHABILITATION CENTER'S INVENTORY. IT IS NOT KNOWN AT WHAT FACILITY THE PATIENT HAD THE ORIGINAL PORT IMPLANTED. THE PATIENT CONDITION IS FINE. THE REHAB FACILITY CONTACTED NAVILYST MEDICAL AFTER RESEARCHING THE PORT'S MARKINGS ON THE INTERNET. THEY WERE PROVIDED WITH INFORMATION TO RETURN THE DEVICE, AND SUPPOSEDLY DID SO, HOWEVER, THE DEVICE HAS NEVER BEEN RECEIVED AT ANY NAVILYST MEDICAL/ANGIODYNAMICS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    433225 NAVILYST MEDICAL PORT & CATHETER, IMPLANTED, SUBCUTANEOUS LJT NAVILYST MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1