BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESTEP 20G X 3/4 STRAIGHT

    MDR report key: 1461431 · Received May 18, 2009

    Report

    Report Number
    3006260740-2009-00175
    Event Type
    Malfunction
    Date Received
    May 18, 2009
    Report Date
    May 12, 2009
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    FPA
    PMA / PMN Number
    K040527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MFR FOR EVALUATION. A CHR REVIEW SHOWED ONE OTHER SIMILAR PRODUCT COMPLAINT FILE(S) FROM THIS LOT. (221462)

    Description of Event or Problem · 1

    THE HUBER WAS FOUND TO LEAK WHERE THE NEEDLE MEETS THE OVAL TOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFESTEP 20G X 3/4 STRAIGHT FPA C. R. BARD INC. (BASD) D901603

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention