BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PORT-A-CATH

    MDR report key: 2081639 · Received April 26, 2011

    Report

    Report Number
    2081639
    Event Type
    Injury
    Date Received
    April 26, 2011
    Date of Event
    April 12, 2011
    Report Date
    April 25, 2011
    Manufacturer
    BARD ACCESS SYSTEM
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    HI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PORT-A-CATH LEAKING PER PATIENT. RECEIVED A CALL FROM THE PATIENT ON (B)(6) 2011 INFORMING US THAT HIS PORT-A-CATH WAS LEAKING AND WANTED TO ALERT US OF THE INFORMATION. HE TOLD US THAT IT WOULD BE REMOVED THE FOLLOWING WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PORT-A-CATH PICC LINE LJT BARD ACCESS SYSTEM 1808001 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention