BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    GROSHONG PICC

    MDR report key: 1062429 · Received June 6, 2008

    Report

    Report Number
    1062429
    Event Type
    Malfunction
    Date Received
    June 6, 2008
    Date of Event
    May 21, 2008
    Report Date
    June 6, 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 LINE PLACEMENT DONE PER PICC RN WITH 5 FRENCH DUAL LUMEN CATHETER WITH GOOD BLOOD RETURN AND BOTH PORTS FLUSHED WELL. 34 CM INSERTED WITH 11 CM REMAINING OUT. PLACEMENT CONFIRMED BY CXR AND RADIOLOGIST. WHEN IRRIGATING CATHETER, THERE WAS LEAKAGE BY THE WINGS, FLOOR NURSE AND RADIOLOGIST ADVISED. PT SENT TO SPECIALS FOR INSERTION OF ANOTHER LINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GROSHONG PICC CATHETER, PICC LJS BARD ACCESS SYSTEMS * RERJ0460

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR