BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HICKMAN CATHETER

    MDR report key: 9729067 · Received February 18, 2020

    Report

    Report Number
    MW5093087
    Event Type
    Injury
    Date Received
    February 18, 2020
    Date of Event
    February 1, 2020
    Report Date
    February 13, 2020
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJS
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PT'S INITIAL: (B)(6). DATE OF AWARENESS: 02/13/2020. REMS ID: (B)(4). PRESCRIBER REMS ID: (B)(4). INITIAL REPORTER: PHARMACIST. PT ADMITTED (B)(6) 2020 - (B)(6) 2020 TO (B)(6) FROM PH W/ C/O LEAKING FROM AROUND HIS HICKMAN CATHETER SINCE LAST NIGHT AND INCREASED EDEMA AND ABDOMINAL SWELLING. HICKMAN CATHETER DYSFUNCTION, LEAKAGE VS. SITE INFECTION, HAS MILD YELLOWISH DISCHARGE AND TENDERNESS; CHRONIC ERYTHEMA D/T DRESSING, GIVEN IV ABX AND TRANSITIONED PO ABX (TREATED FOR LOCAL CELLULITIS). VOLUME OVERLOADED WAS GIVEN IV DIURETICS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    187222 HICKMAN CATHETER CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR