BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EBCIOR BREAST BIOPSY PROBE

    MDR report key: 3933764 · Received April 3, 2014

    Report

    Report Number
    2020394-2014-00128
    Event Type
    Malfunction
    Date Received
    April 3, 2014
    Date of Event
    December 5, 2013
    Report Date
    March 5, 2014
    Manufacturer
    BARD PERIPHERAL VASCULAR, INC.
    Product Code
    KNW
    PMA / PMN Number
    K051158
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER HAS BEEN PROVIDED AND THE INVESTIGATION IS CURRENTLY UNDERWAY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PRIOR TO OPENING THE PACKAGE, IT WAS NOTED THAT THE PLASTIC TRAY WAS CRACKED AND THE STERILITY WAS COMPROMISED. THE DEVICE WAS NOT USED ON THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    200550 EBCIOR BREAST BIOPSY PROBE KNW BARD PERIPHERAL VASCULAR, INC. VT13E0672

    Patients

    Seq Age Sex Outcome Treatment
    1