BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KI

    MDR report key: 2338915 · Received November 4, 2011

    Report

    Report Number
    3006260740-2011-00344
    Event Type
    Malfunction
    Date Received
    November 4, 2011
    Date of Event
    October 11, 2011
    Report Date
    October 12, 2011
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K034020
    Product Problem
    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 AT THIS TIME FOR EVAL. A LOT HISTORY REVIEW (LHR) OF REVA0412 SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PICC WAS REMOVED DUE TO STOPPAGE OF TREATMENT. ON REMOVAL IT WAS FOUND TO BE FRACTURED. THE PT DID NOT APPEAR TO HAVE BEEN INJURED OR NEEDED ANY TREATMENT. THE PT WAS NOT RECEIVING TREATMENT AT THAT TIME, BUT PRIOR TO THIS HAD RECEIVED 3 CYCLES OF FEC CHEMOTHERAPY ON (B)(6) 2011. EACH OF THESE CHEMOTHERAPY REGIMENS HAD BEEN DELIVERED WITHOUT ANY INCIDENT PROBLEMS NOTED AT THE TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 4 FR SINGLE LUMEN GROSHONG NXT CLEARVUE BASIC KI LJS C. R. BARD INC. (BASD) REVA0412

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention