BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BILEVEL UNIVERSAL FOLEY CATHETERIZATION PROCEDURE TRAY

    MDR report key: 4254141 · Received November 13, 2014

    Report

    Report Number
    1018233-2014-00310
    Event Type
    Injury
    Date Received
    November 13, 2014
    Report Date
    October 24, 2014
    Manufacturer
    C.R. BARD, INC. (COVINGTON)
    Product Code
    EZC
    PMA / PMN Number
    K910846
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS STILL IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETE, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE FACILITY HAS EXPERIENCED 3 CASES OF (B)(6) FROM THE SAME LOT NUMBER AND SUSPECTS THE KIT MAY BE CAUSING THE (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732909 BILEVEL UNIVERSAL FOLEY CATHETERIZATION PROCEDURE TRAY EZC C.R. BARD, INC. (COVINGTON) NA NGXL0638

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention