BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD PRECISION GUIDE 20 G X 2 1/2 0.91MM X 6.4CM

    MDR report key: 5117610 · Received September 24, 2015

    Report

    Report Number
    MW5056703
    Event Type
    Injury
    Date Received
    September 24, 2015
    Date of Event
    February 2, 2015
    Report Date
    September 24, 2015
    Manufacturer
    BD
    Product Code
    FMI
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    2

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD 2 LOCALIZATION WIRES PLACED IN BREAST BY INTERVENTIONAL RADIOLOGIST. TAKEN TO OPERATING ROOM AND SURGEON REMOVED PORTION OF BREAST TISSUE THAT INCLUDED BOTH WIRES. ONLY 1 WIRE WAS PRESENT IN THE SPECIMEN AS NOTED BY PATHOLOGIST. THIS WAS NOT CAUGHT BY SURGEON. ON (B)(6) 2015, PATIENT REPORTED AN APPROXIMATELY 3 INCH PORTION OF WIRE CAME OUT OF HER BREAST. BELIEVED TO BE ONE OF THE ORIGINAL 2 BREAST WIRES PLACED ON (B)(6) 2015. UNABLE TO LOCATE OTHER PORTION OF BREAST WIRE AS IT WAS 18 CM IN TOTAL LENGTH. BELIEVE WIRE MAY HAVE BEEN SHEARED OFF OR BROKE DURING SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    632577 BD PRECISION GUIDE 20 G X 2 1/2 0.91MM X 6.4CM BREAST LESION LOCALIZATION NEEDLE FMI BD

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Other