BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERGLIDE 20G, 8CM, BASIC KIT

    MDR report key: 4210818 · Received August 1, 2014

    Report

    Report Number
    3006260740-2014-00391
    Event Type
    Malfunction
    Date Received
    August 1, 2014
    Date of Event
    July 11, 2014
    Report Date
    July 18, 2014
    Manufacturer
    BARD ACCESS SYSTEMS INC.
    Product Code
    FOZ
    PMA / PMN Number
    K121073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION. A LOT HISTORY REVIEW (LHR) REVIEW REYB2097 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT (S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    ON (B)(6) 2014 - AS I ADVANCED THE GUIDEWIRE INTO THE VEIN, I FELT RESISTANCE AND IT WOULD NOT GO ANY FARTHER. I THEN ATTEMPTED TO ADVANCE THE CATHETER INTO THE VEIN AND THE WIRE BECAME STUCK IN THE CATHETER AND WOULD NOT MOVE, I HAD TO PULL THE NEEDLE/WIRE OUT OF THE VEIN/ARM AND IT WAS VERY PAINFUL FOR THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    451937 POWERGLIDE 20G, 8CM, BASIC KIT FOZ BARD ACCESS SYSTEMS INC. REYB2097

    Patients

    Seq Age Sex Outcome Treatment
    1