BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KIT

    MDR report key: 2010957 · Received March 4, 2011

    Report

    Report Number
    3006260740-2011-00064
    Event Type
    Injury
    Date Received
    March 4, 2011
    Date of Event
    February 21, 2011
    Report Date
    February 24, 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 MANUFACTURER FOR EVALUATION. A CHR OF (B)(4) SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PICC LINE WAS INSERTED BY THE DOCTOR AND UTILIZED BY NURSING STAFF (ASPIRATED AND FLUSHED). IT WAS LEAKING SO NURSE WAS CALLED TO LOOK AT THE LINE. UPON INSPECTION IT WAS CLEAR THAT THE PICC HAD DISAPPEARED UP THE ARM. A LINEAGRAM WAS DONE AND IT HAD SPLIT IN TWO. HALF HAD MOVED INTO THE LEFT PLEURAL AND HALF JUST BELOW LEFT SUBCLAVIAN. THE LINE WAS REMOVED AND UPON INVESTIGATION THE DOCTOR CONFESSED HE DID NOT ATTACH THE LINE PROPERLY WHEN PLACING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KIT LJS C. R. BARD INC. (BASD) REUK0522

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention