BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 18X1-1/2 SB

    MDR report key: 22531141 · Received July 17, 2025

    Report

    Report Number
    1911916-2025-00527
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    July 7, 2025
    Report Date
    July 22, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903051991
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6) FOLLOW UP FOR DEVICE EVALUATION. A REPORT WAS RECEIVED INDICATING THE PRESENCE OF A LARGE GLOB OF DRIED WHITE MATERIAL AT THE JUNCTION WHERE THE METAL NEEDLE CONNECTS TO THE PINK HUB. TO SUPPORT THE INVESTIGATION, ONE UNPACKAGED SAMPLE AND A CORRESPONDING PHOTOGRAPH WERE SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. A VISUAL INSPECTION OF THE SAMPLE WAS CONDUCTED. THE NEEDLE HUB EXHIBITED AN EPOXY OVERFLOW. THE PHOTOGRAPH CONFIRMED THE CONDITION OBSERVED IN THE RETURNED SAMPLE. NO ADDITIONAL DEFECTS OR IRREGULARITIES WERE IDENTIFIED. THIS ISSUE IS KNOWN TO OCCUR DURING THE ASSEMBLY PROCESS, SPECIFICALLY WHEN A JAM OCCURS AT THE CANNULATOR. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR MATERIAL NUMBER 305199, LOT 1027259. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. CANNULATOR VERIFICATION CONFIRMED THAT THE SETTINGS WERE ACCURATE, AND PRODUCT FLOW WAS CONSISTENT. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLE, THE CUSTOMER-REPORTED CONDITION HAS BEEN CONFIRMED.

    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.

    Description of Event or Problem · 0

    DESCRIPTION: EPOXY ON NEEDLE. EVENT DETAILS: SEVERAL NEEDLES WITH A LARGE GLOB OF DRIED WHITE MATERIAL WHERE THE METAL PART OF THE NEEDLE ATTACHES TO THE PINK HUB. MATERIAL # 305199, BATCH # 1027259.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    914932 NEEDLE 18X1-1/2 SB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 1027259 00382903051991

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown