BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KI

    MDR report key: 2161782 · Received July 8, 2011

    Report

    Report Number
    3006260740-2011-00208
    Event Type
    Injury
    Date Received
    July 8, 2011
    Date of Event
    June 16, 2011
    Report Date
    June 16, 2011
    Manufacturer
    C. R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K034020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR AT THIS TIME FOR EVAL. A LOT HISTORY REVIEW (LHR) REVIEW IS NOT POSSIBLE, AS NO MFG LOT NUMBER HAS BEEN PROVIDED BY THE COMPLAINANT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PT HAD PICC REPAIRED IN (B)(6) 2011. HAS BEEN REGULARLY FLUSHED AND DRESSED AND WORKING WELL SINCE REPAIR. PT WOKE UP AT HOME AND REALISED THE PICC HAD MIGRATED INSIDE BUT THE EXTERNAL END CONNECTOR AND DRESSING WAS STILL STUCK TO THE ARM. PICC IS BEING RETURNED- END CONNECTOR NOT AVAILABLE AS DISCARDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention