BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 23GA 1IN

    MDR report key: 22900656 · Received August 26, 2025

    Report

    Report Number
    3002682307-2025-00104
    Event Type
    Malfunction
    Date Received
    August 26, 2025
    Date of Event
    August 7, 2025
    Report Date
    October 8, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 300800 AND LOT NUMBER 250107. THE REVIEW DID NOT REVEAL ANY ABNORMALITIES DETECTED DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, THREE (3) PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURES, WHITE MATTER WAS OBSERVED ON THE CANNULA SURFACE. THE WHITE MATERIAL WAS IDENTIFIED AS EPOXY, WHICH IS THE ADHESIVE USED TO JOIN THE CANNULA TO THE HUB COMPONENT. THIS ISSUE LIKELY OCCURRED DURING THE ASSEMBLY PROCESS, SPECIFICALLY AT THE STAGE WHERE EPOXY IS DISPENSED INTO THE HUB. IT MAY HAVE BEEN CAUSED BY A TEMPORARY STOPPAGE OR A MALFUNCTION IN THE EPOXY DISPENSING EQUIPMENT. AS A RESULT, AN EXCESSIVE AMOUNT OF EPOXY WAS APPLIED, WHICH THEN OVERFLOWED ONTO THE SUBSEQUENT CANNULA, LEADING TO THE OBSERVED DEFECT. GIVEN OUR EXPERIENCE AND SUPPORTED BY THE LOW PERCENTAGE OF DEFECTS IDENTIFIED DURING ROUTINE IN-PROCESS INSPECTIONS, THE LIKELIHOOD OF THIS TYPE OF NON-CONFORMANCE OCCURRING IS CONSIDERED TO BE VERY LOW. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    NEEDLE COVERED BY UNKNOWN MATERIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2657452 NEEDLE 23GA 1IN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON 250107

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown