BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BARD PERIPHERAL VASCULAR

    MDR report key: 1843426 · Received September 21, 2010

    Report

    Report Number
    MW5017536
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    August 23, 2010
    Report Date
    September 21, 2010
    Manufacturer
    BARD PERIPHERAL VASCULAR INC
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A (B)(6) PT WITH BREAST CANCER AND SUSPECTED METS TO HIP WAS HAVING A CT GUIDED BIOPSY AND THE NEEDLE BROKE IN THE PT'S HIP. THE NEEDLE BROKE WHILE BEING EXTRACTED. ORTHOPEDICS WAS NOTIFIED IMMEDIATELY. THE PT WAS ADMITTED AND TAKEN TO SURGERY THE NEXT DAY WHERE THE REMAINING PORTION OF THE NEEDLE WAS REMOVED, AND AN OPEN BIOPSY OF THE LEFT HIP WAS PERFORMED. UNFORTUNATELY, THE RESULTS WERE POSITIVE FOR METASTATIC BREAST CANCER. THE PT WAS DISCHARGED ON (B)(6)2010 IN STABLE CONDITION. THE MFR WAS NOTIFIED AND IS SENDING A KIT FOR THE RETURN OF THE BROKEN NEEDLE. DIAGNOSIS OR REASON FOR USE: CT BIOPSY OF LEFT HIP TO RULE OUT METASTATIC CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BARD PERIPHERAL VASCULAR OSTYCUT BIOPSY NEEDLE -10CM- KNW BARD PERIPHERAL VASCULAR INC ANUA2501

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Disability