BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NORPORT SINGLE LUMEN PORT

    MDR report key: 8587006 · Received May 7, 2019

    Report

    Report Number
    1450392-2019-00002
    Event Type
    Malfunction
    Date Received
    May 7, 2019
    Date of Event
    March 25, 2019
    Report Date
    April 30, 2019
    Manufacturer
    NORFOLK MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    PMA / PMN Number
    K111101
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COULD NOT BE REVIEWED BECAUSE IT WAS NOT RETURNED. THEREFORE, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE, AND A DEFINITIVE ROOT CAUSE IS UNKNOWN. BECAUSE THE LOT NUMBER WAS PROVIDED, A MANUFACTURING REVIEW WAS PERFORMED AS WELL AS TESTING OF DEVICES FROM DIFFERENT LOTS. THERE WERE NO FAILURES NOTED. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT APPROXIMATELY 3-YEARS POST-PORT PLACEMENT, THE PORT HAD COME APART. IT WAS FURTHER REPORTED THAT THE PORT WAS REMOVED FROM THE PATIENT AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    382414 NORPORT SINGLE LUMEN PORT PORT AND CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT NORFOLK MEDICAL PRODUCTS, INC. NM1510B

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention