BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERGLIDE MIDLINE CATHETER FULL KIT (20G) (10CM)

    MDR report key: 4093154 · Received August 21, 2014

    Report

    Report Number
    3006260740-2014-00426
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    July 17, 2014
    Report Date
    July 17, 2014
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    FOZ
    PMA / PMN Number
    K121073
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A LOT HISTORY REVIEW (LHR) OF REYF0359 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINTS FROM THIS LOT NUMBER. THE MFR HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON.

    Description of Event or Problem · 1

    ON (B)(6) 2014 INSERTED THE PRODUCT AND WHEN ATTEMPTING TO REMOVE, THE PRODUCT WAS STUCK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506876 POWERGLIDE MIDLINE CATHETER FULL KIT (20G) (10CM) FOZ BARD ACCESS SYSTEMS REYF0359

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention