BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GROSHONG NXT CLEARVUE 4 FR SL PICC NURSING BASIC TRAY

    MDR report key: 1833701 · Received September 10, 2010

    Report

    Report Number
    3006260740-2010-00268
    Event Type
    Injury
    Date Received
    September 10, 2010
    Date of Event
    July 7, 2010
    Report Date
    September 3, 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 EVALUATION. A CHR REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    PATIENT GOT A VENOUS THROMBUS AFTER THE PICC WAS PLACED. IT IS NOT KNOWN HOW MANY DAYS AFTER THE PICC PLACEMENT THEY GOT THE THROMBUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GROSHONG NXT CLEARVUE 4 FR SL PICC NURSING BASIC TRAY LJS C.R. BARD, INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention