BEUDAMED
    FDA Adverse Event Summary report: N

    30328 11GX6IN BN MARR SNARECOIL NDLE

    MDR report key: 558291 · Received May 6, 2004

    Report

    Report Number
    1282497-2004-00011
    Date Received
    May 6, 2004
    Date of Event
    March 29, 2004
    Report Date
    April 5, 2004
    Manufacturer
    OUTSIDE VENDOR-RANFAC CORPORATION
    Product Code
    KNW
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED TO TYCOHEALTHCARE KENDALL THAT DR, A HEMO/ONC DOCTOR REPORTED THAT ONCE THE LEVER WAS ACTIVATED SECURING THE BONE SPECIMEN, SHE ATTEMPTED TO REMOVE THE NEEDLE FROM THE PT. THE HANDLE AND OUTER PORTION OF THE NEEDLE SHAFT WERE REMOVED AND THE INTERNAL PORTION REMAINED IN THE PT, REQUIRING REMOVAL USING STERILE PLIERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 30328 11GX6IN BN MARR SNARECOIL NDLE BONE MARROW BIOPSY NEEDLE KNW OUTSIDE VENDOR-RANFAC CORPORATION * 10704

    Patients

    Seq Age Sex Outcome Treatment
    1 * Other