BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFESTEP 20G X 3/4 STRAIGHT

    MDR report key: 1424960 · Received April 28, 2009

    Report

    Report Number
    3006260740-2009-00148
    Event Type
    Malfunction
    Date Received
    April 28, 2009
    Report Date
    April 6, 2009
    Manufacturer
    C. R. BARD INC. (BASD)
    Product Code
    FPA
    PMA / PMN Number
    K040527
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 OF THE RETURNED SAFESTEP INFUSION SET. A CHR OF LOT #D824110 SHOWED THREE OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT. (220367, 220369 AND 220368).

    Description of Event or Problem · 1

    DURING 46 HOUR INFUSION, THE SAFESTEP NEEDLE LEAKED WHERE THE PLASTIC MEETS THE METAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SAFESTEP 20G X 3/4 STRAIGHT FPA C. R. BARD INC. (BASD) D824110

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention