BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NORPORT SINGLE LUMEN PORT

    MDR report key: 9570604 · Received January 9, 2020

    Report

    Report Number
    1450392-2020-00001
    Event Type
    Malfunction
    Date Received
    January 9, 2020
    Date of Event
    December 6, 2019
    Report Date
    January 9, 2020
    Manufacturer
    NORFOLK MEDICAL PRODUCTS, INC.
    Product Code
    LJT
    PMA / PMN Number
    K111101
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE RETURNED PRODUCT CONTAINED BLOOD/DEBRIS INSIDE THE DISTAL END OF THE CATHETER. IT IS UNCLEAR IF THIS BLOOD/DEBRIS EXISTED PRIOR TO EXPLANT, OR IF IT WAS THE RESULT OF REMOVING THE PORT. PLASTIC "SCARRING" ON THE BOTH THE RETAINER AND BASE WAS VISIBLE AS WELL. THERE WAS ALSO DAMAGE OBSERVED ON THE SEPTUM LANDING AND THREE (3) SCORE MARKS ON THE RETAINER LANDING. THE DAMAGE NOTED ON THE SEPTUM LANDING AND RETAINER LANDING IS UNUSUAL AS INSPECTION OF SEVERAL ASSEMBLED UNITS DOES NOT SHOW ANY SIMILAR OBSERVATIONS. ANALYSIS OF THE PORT SEPTUM SHOWED THE UNIT HAD BEEN ACCESSED APPROXIMATELY FIVE (5) TIMES. THE IFUS STATE THE PORT SHOULD BE ASPIRATED BEFORE BEGINNING ANY TREATMENT AND THAT A FAILURE TO ASSESS PATENCY BEFORE AN INJECTION MAY LEAD TO DEVICE FAILURE OR RUPTURE. THIS DEFECT COULD NOT BE REPRODUCED AT NORFOLK MEDICAL AND REVIEW OF SAMPLE PRODUCT SHOWED NO SIGNS OF SUCH A DEFECT. BECAUSE THE LOT NUMBER WAS PROVIDED, A MANUFACTURING REVIEW WAS PERFORMED AS WELL AS TESTING OF DEVICES FROM DIFFERENT LOTS. THERE WE NO FAILURES OBSERVED. AS SUCH, THE INVESTIGATION OF THE REPORTED EVENT IS INCONCLUSIVE, AND A DEFINITIVE ROOT CAUSE IS UNKNOWN. UPON RECEIPT OF NEW OR ADDITIONAL INFORMATION, A FOLLOW-UP REPORT WILL BE SUBMITTED AS APPLICABLE. (B)(4).

    Description of Event or Problem · 1

    PATIENT WAS REFERRED TO HAVE DEVICE REMOVED DUE TO COMPLICATIONS DURING INFUSION OF MEDICATION. DURING EXPLANTATION OF DEVICE, SURGICAL STAFF NOTICED THE TOP SECTION OF THE DEVICE WAS COMPLETELY SEPARATED FROM THE BOTTOM/BASE OF THE PORT. STAFF STATES THEY BELIEVE THE PORT BECAME SEPARATED PRIOR TO PORT BEING REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    35402 NORPORT SINGLE LUMEN PORT PORT AND CATHETER, IMPLANTED, SUBCTUANEOUS, INTRAVASCULAR LJT NORFOLK MEDICAL PRODUCTS, INC. NM1909C

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention