BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KIT

    MDR report key: 1895420 · Received November 4, 2010

    Report

    Report Number
    3006260740-2010-00329
    Event Type
    Injury
    Date Received
    November 4, 2010
    Date of Event
    October 15, 2010
    Report Date
    October 29, 2010
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K034020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SW
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVAL. A CHR REVIEW SHOWED TWO OTHER SIMILAR PRODUCT COMPLAINT FILE(S) FROM THIS LOT. ((B)(4)).

    Description of Event or Problem · 1

    THE PT GOT A VENOUS THROMBOSIS IN THE ARM 10 DAYS AFTER HE GOT HIS PICC LINE. PT STILL HAS THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KIT LJS C. R. BARD INC. (BASD) REUB0759

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention