BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESTEP 20G X 3/4 STRAIGHT

    MDR report key: 1479270 · Received July 1, 2009

    Report

    Report Number
    3006260740-2009-00233
    Event Type
    Malfunction
    Date Received
    July 1, 2009
    Date of Event
    June 12, 2009
    Report Date
    June 12, 2009
    Manufacturer
    C.R. BARD INC. (BASD)
    Product Code
    FPA
    PMA / PMN Number
    K040527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    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 ON THE COMPLAINT SAMPLE. THE LEAK PATH WAS LOCATED ALONG THE INTERFACE BETWEEN THE PROXIMAL END OF THE NEEDLE AND THE EXTENSION SET TUBING. A CHR OF LOT # D901603 SHOWED TWO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT. (B) (4).

    Description of Event or Problem · 1

    THE PATIENT CAME IN BECAUSE THE NEEDLE WAS LEAKING CHEMO ONTO HIS CHEST. THE DEVICE WAS PLACED (B) (6) 2009.

    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