BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR SL GROSHONG NXT CLEARVUE BASIC KIT

    MDR report key: 3851829 · Received April 11, 2014

    Report

    Report Number
    3006260740-2014-00177
    Event Type
    Malfunction
    Date Received
    April 11, 2014
    Date of Event
    March 18, 2014
    Report Date
    March 18, 2014
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K034020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT HISTORY REVIEW (LHR) OF REVC1880 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER. THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION.

    Description of Event or Problem · 1

    THE NURSE FOUND THE CATHETER HAD BEEN FRACTURED IN 49 CM. THE TAIL-END OF THE CATHETER HAD BEEN OUT OF THE TRANSPARENT DRESSING. THE TRANSFUSION LIQUID HAD BEEN LEAKING. THE CATHETER HAD SLID OUT 10CM ALONG THE DIRECTION OF PUNCTURE POINT. PULLED OUT THE CATHETER AND CHANGED ANOTHER PICC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    221255 4 FR SL GROSHONG NXT CLEARVUE BASIC KIT LJS C.R. BARD, INC. (BASD) REVC1880

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention