BEUDAMED
    FDA Adverse Event Summary report: N

    SMART PORT

    MDR report key: 9739679 · Received February 20, 2020

    Report

    Report Number
    MW5093174
    Date Received
    February 20, 2020
    Date of Event
    February 11, 2020
    Report Date
    February 18, 2020
    Manufacturer
    ANGIODYNAMICS
    Product Code
    LJT
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ANGIODYNAMICS POWER PORT PLACED ON (B)(6) 2019. PT CAME FOR BLOOD DRAW TODAY AND THIS IS THE 3RD TIME IN A ROW PT HAD DIFFICULTY GETTING BLOOD FOR LABS FROM PORT. REQUIRES SEVERAL FLUSHES AND PT IN SUPINE POSITION WITH LEFT ARM ELEVATED. BLOOD RETURN FOR LAB WAS FINALLY ATTAINED. PORT PLACED (B)(6) 2019 W/O PROBLEMS. CXR SHOWS TIP SVC/RA JCT. THE 'CT' STAMP ON PORT TO INDICATE PRESSURE INJECTION IS BARELY VISIBLE, COULD SEE WHEN I USED MAGNIFIER IN EPIC IMAGING. VERY UNUSUAL TO HAVE PROBLEMS WITH BLOOD RETURN / LAB COLLECTION AND NS FLUSH. FDA SAFETY REPORT ID# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199517 SMART PORT PORT AND CATHETER, IMPLANTED SUBCUTANEOUS, INTRAVASCULAR LJT ANGIODYNAMICS H787CT80STPDV11 5528062

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR