BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERHICKMAN 9.5F DL POLYURETHANE CATHETER

    MDR report key: 4173791 · Received August 7, 2014

    Report

    Report Number
    3006260740-2014-00401
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Report Date
    July 16, 2014
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    PMA / PMN Number
    K061179
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, 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) OF REYC1187 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    (B)(6) 2014 - HAD A STERILITY ISSUE WITH A POWERHICKMAN CATHETER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    463737 POWERHICKMAN 9.5F DL POLYURETHANE CATHETER LJS BARD ACCESS SYSTEMS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention