BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 22394803 · Received July 3, 2025

    Report

    Report Number
    1911916-2025-00481
    Event Type
    Malfunction
    Date Received
    July 3, 2025
    Date of Event
    June 25, 2025
    Report Date
    July 15, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    GAA
    UDI-DI
    00382903051809
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11: A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION. A REPORT WAS RECEIVED INDICATING THAT THE NEEDLE MAY HAVE CAUSED CORING OF THE MEDICATION VIAL. TO SUPPORT THE INVESTIGATION, ONE SAMPLE, RECEIVED WITHOUT ITS PACKAGING BLISTER, WAS SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. A VISUAL INSPECTION WAS CONDUCTED AT 30X MAGNIFICATION. NO DAMAGE, DEFECTIVE GRINDING, OR HOOKS WERE OBSERVED. THE BEVELS AND ETCHING APPEARED TO BE WITHIN ACCEPTABLE STANDARDS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR MATERIAL NUMBER 305180, LOT 5002105. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. ADDITIONALLY, NO RELATED QUALITY NOTIFICATIONS WERE FOUND. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLE, THE REPORTED ISSUE COULD NOT BE CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED CORING. VERBATIM: MATERIAL #305180 LOT #5002105 DURING MEDICATION PREPARATION, THE NEEDLE CREATING A CORING OF THE MEDICATION VIAL, RESULTING A SMALL PIECE OF THE RUBBER STOPPER FROM THE MEDICATION VIAL BEING REMOVED WITH THE NEEDLE AND FALLING INTO THE SYRINGE.

    Description of Event or Problem · 0

    NO HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2102115 NEEDLE 18X1-1/2 BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BECTON DICKINSON 5002105 00382903051809

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown