BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAVILYST MEDICAL

    MDR report key: 2234012 · Received August 31, 2011

    Report

    Report Number
    1317056-2011-00083
    Event Type
    Injury
    Date Received
    August 31, 2011
    Date of Event
    May 17, 2011
    Report Date
    August 4, 2011
    Manufacturer
    NAVILYST MEDICAL
    Product Code
    LJT
    PMA / PMN Number
    K991897
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS STILL ON-GOING. NAVILYST MEDICAL IS IN THE PROCESS OF OBTAINING ADD'L INFO PERTAINING TO THIS EVENT, INCLUDING DETERMINING THE AVAILABILITY OF A SAMPLE FOR EVAL. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL MEDWATCH WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    EVENT WAS REPORTED TO (B)(6) BY THE PT. HE INDICATED THAT HE HAD A CHEST PORT IMPLANTED ON HIS RIGHT SIDE AT (B)(6) HOSPITAL IN (B)(6). ON (B)(6), 2011. THE 2ND TIME THE PORT WAS ACCESSED, THE PORT CRACKED WHEN THE NEEDLE WAS INSERTED AND CHEMO DRUGS LEAKED INTO THE PORT POCKET. THE PORT WAS REMOVED ON (B)(6), 2011 AND A NEW CHEST PORT WAS PLACED ON THE PT'S LEFT SIDE. THE PT'S REPORT STATED THAT HE "HAD TO BE INJECTED NUMEROUS TIMES TO COUNTERACT THE EFFECTS OF THE LEAK." IT HAS NOT YET BEEN DETERMINED IF THE USED PORT IS AVAILABLE FOR RETURN TO (B)(6) MEDICAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAVILYST MEDICAL PORT & CATHETER, IMPLANTED, SUBCUTANEOUS LJT NAVILYST MEDICAL NA 1345377

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention