BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NEEDLE 27GA 1-1/2IN

    MDR report key: 21469379 · Received February 26, 2025

    Report

    Report Number
    1911916-2025-00153
    Event Type
    Injury
    Date Received
    February 26, 2025
    Date of Event
    February 14, 2025
    Report Date
    March 16, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    30382903016298
    PMA / PMN Number
    K021475
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, 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 THE NEEDLE SNAPPED AND REMAINED IN THE PATIENT. TO AID IN THE INVESTIGATION, THREE SAMPLES IN SEALED PACKAGING BLISTERS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED WITH 30X MAGNIFICATION. NO DEFECTS OR IMPERFECTIONS WERE OBSERVED. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 301629, LOT 4178893. 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. 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

    NO ADDITIONAL INFORMATION RECEIVED.

    Description of Event or Problem · 0

    MATERIAL # 301629. BATCH # 4212478. VERBATIM: (B)(6) RECEIVED A COMPLAINT VIA PHONE. PERFORMING A THYROID BIOPSY THE NEEDLE SNAP AND WAS STUCK IN THE PATIENT¿S NECK AND THE PATIENT HAD TO HAVE SURGERY TO REMOVE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1039274 NEEDLE 27GA 1-1/2IN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 4178893 30382903016298

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention