BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POWERPICC SOLO 4F SL CATHETER BASIC TRAY

    MDR report key: 3954810 · Received July 17, 2014

    Report

    Report Number
    3006260740-2014-00361
    Event Type
    Injury
    Date Received
    July 17, 2014
    Date of Event
    June 18, 2014
    Report Date
    June 24, 2014
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    PMA / PMN Number
    K0772230
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER HAS RECEIVED THE SAMPLE AND WILL BE EVALUATED. RESULTS ARE EXPECTED SOON. A LOT HISTORY REVIEW (LHR) OF REXK0899 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE THE GUIDEWIRE DAMAGED DURING ITS REMOVAL THROUGH THE NEEDLE. A PART OF GUIDEWIRE STAYED IN THE RIGHT HUMERAL VEIN OF THE PATIENT. THE USER HAD TO CHANGE THE GUIDE WIRE TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    420285 POWERPICC SOLO 4F SL CATHETER BASIC TRAY LJS BARD ACCESS SYSTEMS REXK0899

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention