BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIGID ENDOSCOPIC NEEDLE

    MDR report key: 11884615 · Received May 26, 2021

    Report

    Report Number
    11884615
    Event Type
    Malfunction
    Date Received
    May 26, 2021
    Date of Event
    May 4, 2021
    Report Date
    May 21, 2021
    Manufacturer
    UROPLASTY, INC.
    Product Code
    FBK
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    WA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 1

    THE NEEDLE BROKE WHEN ATTEMPTING TO INJECT MICROPLASTIC. THE NEEDLE BROKE OUTSIDE OF PATIENT AND FELL ONTO THE FLOOR. A NEW NEEDLE HAD TO BE OPENED TO COMPLETE THE PROCEDURE. BROKEN NEEDLE HAD PATIENT CONTACT BUT NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    781140 RIGID ENDOSCOPIC NEEDLE ENDOSCOPIC INJECTION NEEDLE, GASTROENTEROLOGY-UROLOGY FBK UROPLASTY, INC. MRN-420 83971

    Patients

    Seq Age Sex Outcome Treatment
    1 28470 DA