BEUDAMED
    FDA Adverse Event Summary report: N

    BARD GROSHONG NXT CLEARVUE

    MDR report key: 2840527 · Received October 11, 2012

    Report

    Report Number
    2840527
    Date Received
    October 11, 2012
    Date of Event
    September 21, 2012
    Report Date
    October 11, 2012
    Manufacturer
    BARD ACCESS SYSTEM INC.
    Product Code
    DQY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    ID, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD A ANTECUBITAL PICC LINE INSERTED ON (B)(6) 2012. DISCHARGED TO A LONG TERM CARE FACILITY. READMITTED TO COMMUNITY HOSPITAL ON (B)(6) 2012 WHEN THE PICC LINE WAS LEAKING. X-RAYS SHOWED A FRAGMENT HAD DRIFTED IN TO THE SVC, REQUIRING SURGICAL REMOVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD GROSHONG NXT CLEARVUE 4FR SINGLE LUMEN PICC DQY BARD ACCESS SYSTEM INC. REF# 7617400 REWE0364

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other| R