BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    4 FR SL POWERPICC SOLO CATHETER, BASIC

    MDR report key: 2904163 · Received January 3, 2013

    Report

    Report Number
    3006260740-2013-00004
    Event Type
    Malfunction
    Date Received
    January 3, 2013
    Date of Event
    August 19, 2011
    Report Date
    December 12, 2012
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    LJS
    PMA / PMN Number
    K072230
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVAL, AS THE DEVICE WAS DISCARDED AFTER THE EVENT OCCURRED. A LOT HISTORY REVIEW (LHR) OF REUG0391 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT MALPOSITION OCCURRED POST POWER INJECTION IN (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2478 4 FR SL POWERPICC SOLO CATHETER, BASIC LJS C. R. BARD INC. (BASD) REUG0391

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention