BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 30X1/2 RB

    MDR report key: 21704050 · Received March 26, 2025

    Report

    Report Number
    1911916-2025-00241
    Event Type
    Malfunction
    Date Received
    March 26, 2025
    Date of Event
    March 20, 2025
    Report Date
    April 2, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION: IT WAS REPORTED THERE WAS A STREAM OF LIQUID WAS COMING OUT OF THE NEEDLE. TO AID IN THE INVESTIGATION, NINETY SAMPLES IN SEALED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. FIFTY SAMPLES WERE RANDOMLY SELECTED FOR INVESTIGATION. A VISUAL INSPECTION WAS PERFORMED, AND NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. EACH SAMPLE WAS THEN ASSEMBLED TO A SYRINGE WITH SALINE SOLUTION. THE SOLUTION WAS EXPELLED WITH A NORMAL FLOW; NO LEAKAGE OF ANY KIND WAS OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305106, LOT 4081032. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED.

    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.

    Description of Event or Problem · 0

    MATERIAL #305106. LOT #4081032. IT WAS REPORTED BY CUSTOMER THAT OPENED NEW BOX- DOING A BOTOX PROCEDURE AND WHEN THE FIRST INJECTION WAS DONE, THEY NOTICED A STREAM OF LIQUID WAS COMING OUT OF THE NEEDLE. POSSIBLE HOLE IN NEEDLE. VERBATIM: COMPLAINT RECEIVED BY PHONE CALL ON 20-MAR-2025 REPRESENTATIVE SAMPLES AVAILABLE FROM THE SAME LOT. NO ADVERSE EVENT/ PT INJURY OPENED NEW BOX- DOING A BOTOX PROCEDURE AND WHEN THE FIRST INJECTION WAS DONE, THEY NOTICED A STREAM OF LIQUID WAS COMING OUT OF THE NEEDLE. POSSIBLE HOLE IN NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2472468 NEEDLE 30X1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4081032

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown