BEUDAMED
    FDA Adverse Event Summary report: N

    GROSHONG NXT CLEARVUE 4F SL PICC BASIC TRAY

    MDR report key: 3812315 · Received May 6, 2014

    Report

    Report Number
    3006260740-2014-00233
    Date Received
    May 6, 2014
    Date of Event
    April 9, 2014
    Report Date
    April 16, 2014
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    PMA / PMN Number
    K034020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OR REXJ0362 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    THEY HAVE REPORTED AT THE END OF PROCEDURE INFUSING THE PATIENT FELT PAIN AFTER MAKING THE ECHO. THEY NOTED THE UNDERSKIN INFLAMED BY THE DRUG EXTRAVASATION AND THE CATHETER WAS FOUND BROKEN. THEY REMOVE THE CATHETER. THEY MADE A MEDICAL TREATMENT TO THE PATIENT AFTER REMOVAL ACCORDING TO THE PROTOCOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271973 GROSHONG NXT CLEARVUE 4F SL PICC BASIC TRAY LJS BARD ACCESS SYSTEMS REXJ0362

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention