BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERGLIDE MIDLINE CATH FULL KIT (20G) (8CM)

    MDR report key: 3810824 · Received March 21, 2014

    Report

    Report Number
    3006260740-2014-00135
    Event Type
    Malfunction
    Date Received
    March 21, 2014
    Date of Event
    February 27, 2014
    Report Date
    February 27, 2014
    Manufacturer
    C.R. BARD, INC. (BASD)
    Product Code
    FOZ
    PMA / PMN Number
    K121073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.

    Description of Event or Problem · 1

    I HAD A POWERGLIDE CAUSE A VEIN SPASM ON (B)(6). WE WERE UNABLE TO REMOVE THE DEVICE FROM THE PATIENT AND IN ADDITION WE COULD NOT SEPARATE THE GUIDEWIRE AND PLASTIC HOUSING FROM THE CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    169361 POWERGLIDE MIDLINE CATH FULL KIT (20G) (8CM) FOZ C.R. BARD, INC. (BASD) REXL0856

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention