BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESTEP 22G X 3/4 STRAIGHT

    MDR report key: 1366076 · Received March 20, 2009

    Report

    Report Number
    3006260740-2009-00120
    Event Type
    Malfunction
    Date Received
    March 20, 2009
    Date of Event
    January 12, 2009
    Report Date
    March 2, 2009
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    FPA
    PMA / PMN Number
    K040527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT OF A LEAK WAS CONFIRMED, AND WILL BE CONSIDERED MANUFACTURING RELATED. A LEAK WAS DETECTED AT THE NEEDLE HUB. THE LEAK PATH WAS LOCATED ALONG THE INTERFACE BETWEEN THE PROXIMAL END OF THE NEEDLE AND THE EXTENSION SET TUBING. A CHR OF LOT# D818637 SHOWED FOUR OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT. (205901, 207723, 213020, AND 213028).

    Description of Event or Problem · 1

    FAULTY PORT NEEDLE - IV FLUID LEAKING FROM PLASTIC PORT ON TOP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFESTEP 22G X 3/4 STRAIGHT FPA C.R. BARD, INC. (BASD) D818637

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention