BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 25X1-1/2 RB

    MDR report key: 22157604 · Received June 6, 2025

    Report

    Report Number
    1911916-2025-00393
    Event Type
    Malfunction
    Date Received
    June 6, 2025
    Date of Event
    May 21, 2025
    Report Date
    June 6, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903051275
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Additional Manufacturer Narrative · 0

    PR (B)(4) FOLLOW UP. IT WAS REPORTED THE NEEDLE BROKE AT HUB WHILE INJECTING A PATIENT DURING ROBOTIC SURGERY. OUR QUALITY TEAM HAS COMPLETED A DEVICE HISTORY RECORD REVIEW FOR MATERIAL NUMBER 305127 AND LOT NUMBER 4247061. THE REVIEW DID NOT IDENTIFY ANY ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE DEFECT, AND ALL QUALITY TESTS WERE WITHIN SPECIFICATION. DUE TO THE UNAVAILABILITY OF A SAMPLE FOR RETURN, A COMPREHENSIVE SAMPLE INVESTIGATION COULD NOT BE CONDUCTED. CONSEQUENTLY, THE EXACT CAUSE OF THIS INCIDENT REMAINS UNDETERMINED. SHOULD YOU ENCOUNTER ANY FURTHER ISSUES WITH OUR PRODUCT, WE WOULD APPRECIATE THE OPPORTUNITY TO PERFORM A DETAILED ANALYSIS. AT THIS TIME, NO FURTHER ACTION IS DEEMED NECESSARY.

    Description of Event or Problem · 0

    MATERIAL: 305127 BATCH#: 4247061. IT WAS REPORTED BY THE CUSTOMER THAT NEEDLE BROKE AT HUB WHILE INJECTING PATIENT DURING ROBOTIC SURGERY. RCC RECEIVED A COMPLAINT VIA EMAIL. 25-GAUGE NEEDLE BROKE AT HUB WHILE INJECTING PATIENT DURING ROBOTIC SURGERY. THE NEEDLE MIGRATED TO THE PATIENT'S LUNG AND WAS REMOVED VIA ROBOTIC EXPLORATORY SURGERY. WHAT WAS THE ORIGINAL INTENDED PROCEDURE? ROBOTIC THYMECTOMY WHAT PROBLEM DID THE USER HAVE: DEVICE FAILED (E.G. BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING) ; DEVICE MALFUNCTION - THAT IS, THE DEVICE DID NOT DO WHAT IT WAS SUPPOSED TO DO. THERAPIES BEING USED ON THE PATIENT AT THE TIME OF THE EVENT THAT MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT: NOT APPLICABLE; NOT KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619636 NEEDLE 25X1-1/2 RB NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE FMI BECTON DICKINSON 4247061 30382903051275

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Female Required Intervention