BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAMSHIDI MENGHINI SOFT TISSUE BIOPSY TRAYS

    MDR report key: 878608 · Received June 11, 2007

    Report

    Report Number
    878608
    Event Type
    Malfunction
    Date Received
    June 11, 2007
    Date of Event
    May 11, 2007
    Report Date
    June 11, 2007
    Manufacturer
    CARDINAL HEALTH MEDICAL PRODUCTS AND SERVICES
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MI, US

    Narratives

    Description of Event or Problem · 1

    WHEN PERFORMING LIVER BIOPSY, NEEDLE APPEARED TO BE NOT SHARP ENOUGH - UNABLE TO PASS THROUGH TISSUE EFFECTIVELY. REPLACED WITH ANOTHER (SAME PRODUCT) AND BIOPSY WAS SUCCESSSFUL. THIS PHYSICIAN REPORTS "ABOUT 4 TO 5 SIMILAR OCCURRENCES WITH THE SAME PRODUCT OVER THE PAST FEW MONTHS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAMSHIDI MENGHINI SOFT TISSUE BIOPSY TRAYS NEEDLE, BIOPSY KNW CARDINAL HEALTH MEDICAL PRODUCTS AND SERVICES UNK L6K320

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR