BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    55 CM FR D/L GROSHONG NXT BASIC WITH TLS

    MDR report key: 3871723 · Received April 17, 2014

    Report

    Report Number
    3006260740-2014-00188
    Event Type
    Malfunction
    Date Received
    April 17, 2014
    Report Date
    March 20, 2014
    Manufacturer
    C. R. BARD, INC. (BASD)
    Product Code
    FOZ
    PMA / PMN Number
    K060341
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR AT THIS TIME, FOR EVAL. A LOT HISTORY REVIEW (LHR) OF REWK0684 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    WE HAVE A LINE THAT WAS TAKEN OUT THAT IS BARD THAT HAS A HOLE IN PRODUCT. THE HOLE IS JUST BELOW THE WHITE (WING TYPE PIECE) WHERE THE BLUE TUBING STARTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236577 55 CM FR D/L GROSHONG NXT BASIC WITH TLS FOZ C. R. BARD, INC. (BASD) REWK0684

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention