BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 FR S/L GROSHONG NXT CLEARVUE

    MDR report key: 1140941 · Received August 28, 2008

    Report

    Report Number
    3006260740-2008-00101
    Event Type
    Injury
    Date Received
    August 28, 2008
    Date of Event
    July 4, 2008
    Report Date
    August 4, 2008
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K034020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVAL. A CHR REVIEW IS NOT POSSIBLE, AS NO MANUFACTURING LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    FOLLOWING UNEVENTFUL INSERTION OF THIS DEVICE, THE PT PRESENTED TO THE HOSP 10 DAYS LATER SAYING HE WOKE UP AND FOUND THE PICC LINE "HUB" LOOSE UNDER THE DRESSING. IT WAS SUBSEQUENTLY DISCOVERED THAT THE PICC LINE HAD BECOME DISCONNECTED FROM ITS HUB AND MIGRATED INTRAVASCULARLY TO LIE TOTALLY WITHIN THE HEART AND PULMONARY VASCULATURE. THIS REQUIRED RADIOLOGICAL REMOVAL. FORTUNATELY THERE WERE NO SEQUELAE TO THE PT APART FROM THE INCONVENIENCE OF THE EXTRACTION PROCEDURE AND SUBSEQUENT PICC REINSERTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 FR S/L GROSHONG NXT CLEARVUE LJS C. R. BARD INC. (BASD) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention