BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HICKMAN S/L CATHETERS

    MDR report key: 8529794 · Received April 18, 2019

    Report

    Report Number
    3006260740-2019-01019
    Event Type
    Malfunction
    Date Received
    April 18, 2019
    Report Date
    April 18, 2019
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    UDI-DI
    00801741051814
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES THREE MALFUNCTION EVENTS. A REVIEW OF THE EVENTS INDICATED THAT MODEL 600524 HICKMAN S/L CATHETERS EXPERIENCED A FLUID LEAK. THESE REPORTS WERE RECEIVED FROM VARIOUS SOURCES. OF THE THREE EVENTS, ALL INVOLVED PATIENTS WITH NO REPORTED INJURY. ONE OF THE PATIENTS IS A (B)(6)-MONTH-OLD BOY WEIGHING (B)(6) KGS. HE WAS INVOLVED IN TWO OF THE COMPLAINTS. THE OTHER PATIENT WAS A (B)(6)-MONTH-OLD BOY ALSO WEIGHING (B)(6) KGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320382 HICKMAN S/L CATHETERS CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS LJS BARD ACCESS SYSTEMS 0600524 HUBV0714 00801741051814

    Patients

    Seq Age Sex Outcome Treatment
    1