BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NIAGARA DIALYSIS CATHETER KIT 13.5 F X 24 CM (SHORT-TERM)

    MDR report key: 3810812 · Received March 21, 2014

    Report

    Report Number
    3006260740-2014-00130
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 16, 2014
    Report Date
    February 24, 2014
    Manufacturer
    C.R. BARD INC. (BASD)
    Product Code
    MPB
    PMA / PMN Number
    K030268
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAD RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.

    Description of Event or Problem · 1

    THE Y PART OF THE TUBING CUT SPONTANEOUSLY ALONE. ANOTHER DEVICE HAS BEEN PLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169360 NIAGARA DIALYSIS CATHETER KIT 13.5 F X 24 CM (SHORT-TERM) MPB C.R. BARD INC. (BASD) REXE1450

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention