BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POWERPICC 4F NURSE BASIC TRAY SL W/MICROINTRO

    MDR report key: 4173798 · Received August 7, 2014

    Report

    Report Number
    3006260740-2014-00399
    Event Type
    Malfunction
    Date Received
    August 7, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 10, 2014
    Manufacturer
    BARD ACCESS SYSTEMS
    Product Code
    LJS
    PMA / PMN Number
    K070996
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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 REWH1627 SHOWED NO OTHER SIMILAR PRODUCT COMPLAINT(S) FROM THIS LOT NUMBER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING INFUSION, THE PATIENT FELT OBVIOUS UNCOMFORTABLE ABOVE THE PUNCTURE SITE. WHEN THE CATHETER WAS REMOVED FOR INSPECTION, SAND HOLES WERE FOUND AT 7CM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    464944 POWERPICC 4F NURSE BASIC TRAY SL W/MICROINTRO LJS BARD ACCESS SYSTEMS REWH1627

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention