BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OTW, XK, 23CM, ST, SPLIT TIP, STANDARD KIT

    MDR report key: 2801164 · Received October 17, 2012

    Report

    Report Number
    3006260740-2012-00372
    Event Type
    Malfunction
    Date Received
    October 17, 2012
    Date of Event
    May 29, 2012
    Report Date
    October 4, 2012
    Manufacturer
    C. R. BARD, INC. (BASD)
    Product Code
    MSD
    PMA / PMN Number
    K090101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. A LOT HISTORY REVIEW (LWR) OF REWD0088 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    HEMODIALYSIS CATHETER WAS PLACED (B)(6) 2012 AND REPLACED ON (B)(6) 2012 BECAUSE THE CUFF WAS EXPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OTW, XK, 23CM, ST, SPLIT TIP, STANDARD KIT MSD C. R. BARD, INC. (BASD) REWD0088

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention