BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESTEP 20G X 3/4 STRAIGHT

    MDR report key: 1459316 · Received June 26, 2009

    Report

    Report Number
    3006260740-2009-00224
    Event Type
    Malfunction
    Date Received
    June 26, 2009
    Report Date
    May 27, 2009
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    FPA
    PMA / PMN Number
    K040527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    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 #D902202 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT.

    Description of Event or Problem · 1

    THE TUBE CONNECTED TO THE PLASTIC DOG TAIL LEAKED 5 FU. NO INJURY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFESTEP 20G X 3/4 STRAIGHT FPA C. R. BARD INC. (BASD) D902202

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention