BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 FR SL GROSHONG NXT CLEARVUE BASIC KIT W/MICROINTRO

    MDR report key: 3925591 · Received June 17, 2014

    Report

    Report Number
    3006260740-2014-00315
    Event Type
    Injury
    Date Received
    June 17, 2014
    Date of Event
    May 17, 2014
    Report Date
    May 26, 2014
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    PMA / PMN Number
    K034020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REXL0688 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PICC WAS FOUND IN THE PATIENT'S BED, IT BROKEN WHERE BLUE END CONNECTS TO EXTENSION LEG. PICC WENT INTO THE PATIENT. VASCULAR WAS UNABLE TO RETRIEVE IT AT THE BEDSIDE. WENT TO OR FOR RETRIEVAL AND SUCCESSFULLY REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355834 4 FR SL GROSHONG NXT CLEARVUE BASIC KIT W/MICROINTRO LJS BARD ACCESS SYSTEMS REXL0688

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention