BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARD

    MDR report key: 442417 · Received February 9, 2003

    Report

    Report Number
    MW1027500
    Event Type
    Other
    Date Received
    February 9, 2003
    Date of Event
    February 5, 2003
    Report Date
    February 9, 2003
    Manufacturer
    C.R. BARD INC.
    Product Code
    KOD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE PACKAGING OF THE PRODUCTS DOES NOT ALLOW THE HEALTH CARE PROVIDER TO MAINTAIN STERILE TECHNIQUE DURING THE PROCEDURE. THE STERILE FIELD AND/OR THE ITEM BEING REMOVED FROM THE CONTAINER ARE CONTAMINATED AS THEY ARE REMOVED FROM THE PACKAGING CONTAINER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD FEMALE CATH KIT - 8 FR - SOFT KOD C.R. BARD INC. * 76GM0115

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other