BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PICC LINE

    MDR report key: 1061169 · Received May 20, 2008

    Report

    Report Number
    1061169
    Event Type
    Malfunction
    Date Received
    May 20, 2008
    Date of Event
    April 3, 2008
    Report Date
    May 20, 2008
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PICC RN EVALUATING PICC LINE FOR PATIENT AND NOTED THAT THE LINE WAS LEAKING. AFTER REMOVING THE TEGADERM DRESSING, SHE FLUSHED THE WHITE PORT OF THE PICC LINE WITH 0.9 NORMAL SALINE AND NOTED A SALINE STREAM SHOOTING FROM THE PICC LINE AT 53CM. SHE FLUSHED THE RED PORT AND NOTED SOME SALINE LEAKING FROM THE SAME AREA. WHEN THE CATHETER EXCHANGE WAS UNSUCCESSFUL, A NEW LINE WAS INSERTED. OUR FACILITY'S PRACTICE IS TO FLUSH THE SYRINGE WITH 5-10CC OF SALINE AFTER EVERY USE OF THE PICC, INCLUDING MEDS AND LAB DRAWS. THE PORTS ARE CLEANED WITH CHLORHEXIDINE PRIOR TO ACCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PICC LINE CATHETER, PICC LJS BARD ACCESS SYSTEMS * RERI0505

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR CARDIAC DRUGS| CARDIAC DRUGS| IMMUNOTHERAPY| IMMUNOTHERAPY