BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LOW PROFILE PORT-A-CATH

    MDR report key: 3003835 · Received March 5, 2013

    Report

    Report Number
    3003835
    Event Type
    Malfunction
    Date Received
    March 5, 2013
    Date of Event
    January 23, 2013
    Report Date
    March 5, 2013
    Manufacturer
    BARD ACCESS SYSTEMS, INC.
    Product Code
    LJT
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    RN WENT TO HEPARIN LOCK PATIENT'S PORT AFTER VANCOMYCIN. THIS RN NOTICED PATIENT'S PORT SITE WAS REDDENED WITH EDEMA. PATIENT'S MOM STATED THE PATIENT HAS BEEN ACCESSED FOR THE PAST 6 MONTHS AND SHE HAS "HAD LOTS OF PROBLEMS WITH IT" SUCH AS "LEAKING FROM THE SITE." THE PORT WAS DE-ACCESSED AND A COLD COMPRESS APPLIED. PATIENT CURRENTLY HAS A PICC. THIS WAS THE FIRST INFUSION OF THIS INPATIENT ADMISSION AND MOM EXPRESSED THIS HAD BEEN HAPPENING AT HOME AS WELL. PORT WAS IN LONGER THAN 5 YEARS. PORT REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    92954 LOW PROFILE PORT-A-CATH PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR LJT BARD ACCESS SYSTEMS, INC. * REPK0455

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR UNKNOWN AT THIS TIME