BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERGLIDE MIDLINE CATHETER, 20G 10CM

    MDR report key: 4173793 · Received August 7, 2014

    Report

    Report Number
    3006260740-2014-00400
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    July 16, 2014
    Report Date
    July 16, 2014
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    FOZ
    PMA / PMN Number
    K121073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER, AT THIS TIME, FOR EVALUATION. A LOT HISTORY REVIEW (LHR) OF REYD1690 SHOWED ONE OTHER SIMILAR PRODUCT (COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    "THE POWER GLIDE WIRE DEPLOYED NORMALLY, THE CATHETER WOULD NOT RELEASE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464959 POWERGLIDE MIDLINE CATHETER, 20G 10CM FOZ BARD ACCESS SYSTEMS REYD1690

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention