BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY

    MDR report key: 3193570 · Received June 25, 2013

    Report

    Report Number
    3006260740-2013-00312
    Event Type
    Injury
    Date Received
    June 25, 2013
    Date of Event
    June 1, 2013
    Report Date
    June 3, 2013
    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 EVALUATION. A LOT HISTORY REVIEW (LHR) OF REVJ0100 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE CATHETER BROKE AND MIGRATED TO THE RIGHT VENTRICLE. THE FIRST PICC WAS REMOVED AND ANOTHER PICC LINE WAS PLACED. AFTER PLACEMENT OF THE SECOND PICC THE PT HAD A CHEST X-RAY TO CONFIRM TIP POSITION AND IT WAS NOTED ON X-RAY THAT A PIECE FROM ABOVE WAS IN PTS RIGHT VENTRICLE. THE PT WAS TAKEN TO INTERVENTIONAL RADIOLOGY AND PIECE OF PICC SNARED AND REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    288934 GROSHONG NXT CLEARVUE 4F SINGLE-LUMEN PICC BASIC TRAY LJS C. R. BARD INC. (BASD) REVJ0100

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention