BEUDAMED
    FDA Adverse Event Other Summary report: N

    NAC-1820MLL

    MDR report key: 1022524 · Received March 24, 2008

    Report

    Report Number
    1056553-2008-00001
    Event Type
    Other
    Date Received
    March 24, 2008
    Report Date
    March 24, 2008
    Manufacturer
    REMINGTON MEDICAL, INC.
    Product Code
    KNW
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    USER CONTACTED SALES DEPARTMENT IN 2008 AND STATED THAT THE NAC-1820MLL (AUTOMATIC CUTTING NEEDLE, MAGNUM LUER LOCK) USED TO PERFORM BIOPSIES ON SOME PATIENTS HAD NOT OBTAINED ADEQUATE CORE SAMPLES ) NO SPECIFIC EVENT DATES WERE GIVEN). THE USER STATED THAT THE PATHOLOGY LAB USED BY THE USER HAD CONTACTED THEM TWICE IN THE PAST WEEK AND REPORTED THAT SAMPLES OBTAINED BY THE NEEDLES DID NOT PROVIDE THE LAB WITH SUFFICIENT TISSUE TO TEST. THEREFORE, THE USER HAD TO CALL PATIENTS IN TO REPEAT THE BIOPSIES. NO ADDITIONAL DETAILS ABOUT THE PATIENTS WERE REPORTED BY THE USER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NAC-1820MLL AUTO. CUTTING NEEDLE, MAGNUM LUER LOCK KNW REMINGTON MEDICAL, INC. NAC-1820MLL 073347

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Other