BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NAVILYST / VAXCEL

    MDR report key: 2043027 · Received March 15, 2011

    Report

    Report Number
    1317056-2011-00025
    Event Type
    Malfunction
    Date Received
    March 15, 2011
    Date of Event
    February 14, 2011
    Report Date
    February 15, 2011
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJT
    PMA / PMN Number
    K942623
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE END DEVICE HAS BEEN RETURNED TO NAVILYST MEDICAL, THE EVALUATION OF THE SAMPLE HAS NOT YET BEEN CONCLUDED. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    AS REPORTED, WHEN AN 8F VALVED CHEST PORT WAS BEING REMOVED AT THE END OF THE PATIENT'S TREATMENT, THE CATHETER TUBING FRACTURED AT THE PORT JUNCTION. THE TUBING DID NOT MIGRATE AND THERE WAS NO PATIENT COMPLICATIONS. THE END USER DOES NOT BELIEVE THEY CUT THE TUBING, AS THE ENDS APPEARED JAGGED, BUT INDICTED THAT "IT COULD BE A SLIM POSSIBILITY." THE PORT HAD BEEN FUNCTIONING PROPERLY UP UNTIL THE EXPLANT PROCEDURE. NO REPLACEMENT PORT WAS PLACED, AS THE PATIENT'S TREATMENT HAD ENDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST / VAXCEL VAXCEL PASV PORT LJT NAVILYST MEDICAL NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1