BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOPRINCE NEEDLE

    MDR report key: 9008464 · Received September 11, 2019

    Report

    Report Number
    MW5089738
    Event Type
    Malfunction
    Date Received
    September 11, 2019
    Date of Event
    August 28, 2019
    Report Date
    September 9, 2019
    Manufacturer
    ARGON MEDICAL DEVICES INC.
    Product Code
    KNW
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT WAS IN OUR DEPT FOR A NATIVE KIDNEY BIOPSY. AFTER THE PROCEDURE WAS DONE, IT WAS NOTICED BY OUR PHYSICIAN ASSISTANT THAT THE BIOPSY DEVICE WAS DAMAGED. SHE SHOWED IT TO DR. THE DEVICE LOOKED LIKE THE OUTER SHEATH HAD BE SPLAYED OPEN. THE GROUP CHECKED ON THE PT UNTIL THE END OF THE DAY AND SHE WAS FINE. FDA SAFETY REPORT ID # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    794606 BIOPRINCE NEEDLE INSTRUMENT, BIOPSY KNW ARGON MEDICAL DEVICES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR