BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE 21X1-1/2 RB

    MDR report key: 24442016 · Received February 25, 2026

    Report

    Report Number
    1911916-2026-00082
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    February 19, 2026
    Report Date
    March 6, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMI
    UDI-DI
    00382903051670
    PMA / PMN Number
    K021475
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. IT WAS REPORTED THE GREEN PART OF THE NEEDLE SEPARATED FROM THE NEEDLE. OUR QUALITY TEAM HAS COMPLETED A DEVICE HISTORY RECORD REVIEW FOR MATERIAL NUMBER 305167 AND LOT NUMBER 5092716. THE REVIEW DID NOT IDENTIFY ANY ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE CONDITION, AND ALL QUALITY TESTS WERE WITHIN SPECIFICATION. DUE TO THE UNAVAILABILITY OF A SAMPLE FOR RETURN, A COMPREHENSIVE SAMPLE INVESTIGATION COULD NOT BE CONDUCTED. CONSEQUENTLY, THE EXACT CAUSE OF THIS INCIDENT REMAINS UNDETERMINED. SHOULD YOU ENCOUNTER ANY FURTHER ISSUES WITH OUR PRODUCT, WE WOULD APPRECIATE THE OPPORTUNITY TO PERFORM A DETAILED ANALYSIS. AT THIS TIME, NO FURTHER ACTION IS DEEMED NECESSARY.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    IT IS REPORTED NEEDLE SEPARATION FROM HUB. DESCRIPTION: FITCH WAS DOING A CORTISONE IN A PATIENT'S LEFT KNEE AND SHE WENT TO REMOVE THE NEEDLE FROM THE PATIENT'S KNEE AND THE GREEN PART OF THE NEEDLE SEPARATED FROM THE NEEDLE ITSELF. THE NEEDLE WAS STUCK IN THE PATIENT'S KNEE AND KIM WAS ABLE TO PULL IT OUT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    120473 NEEDLE 21X1-1/2 RB NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BD MEDICAL (BD WEST) MEDICAL SURGICAL 5092716 00382903051670

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown