BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 21X1 LL ECLIPSE

    MDR report key: 23785788 · Received December 11, 2025

    Report

    Report Number
    3003916417-2025-00289
    Event Type
    Malfunction
    Date Received
    December 11, 2025
    Date of Event
    November 21, 2025
    Report Date
    January 8, 2026
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED

    Additional Manufacturer Narrative · 0

    AN ANALYSIS OF THE BATCH HISTORY (DHR), MAINTENANCE RECORDS, AND QUALITY NOTIFICATIONS WAS CARRIED OUT, AND NO RECORDS POTENTIALLY RELATED TO THE INCIDENT WERE IDENTIFIED. BASED ON THE PHOTO PROVIDED BY THE CUSTOMER, IT WAS POSSIBLE TO CONFIRM THE OCCURRENCE OF FOREIGN MATTER OF THE TYPE COMPONENT FRAGMENTS. THEREFORE, BD CONFIRMS THE COMPLAINT. THE POSSIBLE CAUSE OF THE INCIDENT WAS THE BREAKAGE OF THE GRID USED IN THE NEEDLE ASSEMBLY, WHICH OCCURRED AFTER ASSEMBLY DURING THE NEEDLE EXTRACTION STEP. WE EMPHASIZE THAT THE MANUFACTURING PROCESS IS VALIDATED ACCORDING TO PREVIOUSLY DEFINED ACCEPTANCE CRITERIA, AND THE REPORTED INCIDENT WILL BE MONITORED TO ASSESS POSSIBLE TRENDS. CONSIDERING THAT THIS OCCURRENCE DOES NOT EXCEED THE BATCH¿S ACCEPTABLE QUALITY LIMIT (AQL), NO ADDITIONAL CORRECTIVE OR PREVENTIVE ACTIONS ARE PROPOSED AT THIS TIME.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE 21X1 LL ECLIPSE HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT: UPON OPENING A UNIT OF THE 0.80 X 25 MM HYPODERMIC NEEDLE FOR MEDICATION ASPIRATION, A DEFECT IN THE MATERIAL WAS IDENTIFIED. ATTACHED ARE PHOTOS OF THE BATCH AND THE ITEM WITH THE NON-CONFORMITY OBSERVED. 0.80 X 25 MM BD NEEDLE, BATCH: 5181963.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    552242 BD NEEDLE 21X1 LL ECLIPSE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON IND. CIRURGICAS LTDA 5181963

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown