BEUDAMED
    FDA Adverse Event Other Summary report: N

    BARD CATHETER STYLET

    MDR report key: 753846 · Received August 9, 2006

    Report

    Report Number
    MW1040012
    Event Type
    Other
    Date Received
    August 9, 2006
    Date of Event
    August 8, 2006
    Report Date
    August 9, 2006
    Manufacturer
    BARD UROLOGICAL PRODUCTS
    Product Code
    EZB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    MANUFACUTURER, BARD UROLOGICAL PRODUCTS, HAS NO CLEANING OR STERILIZATION INSTRUCTIONS AVAILABLE FOR CATHETER STYLET 6 FR. REORDER 004036. MANUFACTURER, BARD UROLOGICAL PRODUCTS, HAS DONE NO VALIDATION TESTING FOR STERLIZATION OF PRODUCT FOR USE IN STERILE SURGICAL PROCEDURES. DISTRIBUTED BY: C.R.BARD, INC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD CATHETER STYLET CATHETER STYLET EZB BARD UROLOGICAL PRODUCTS 6 FRENCH 76JGN0229

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other