BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 27X1/2 LL ECLIPSE

    MDR report key: 23458022 · Received November 3, 2025

    Report

    Report Number
    3003916417-2025-00244
    Event Type
    Malfunction
    Date Received
    November 3, 2025
    Date of Event
    October 6, 2025
    Report Date
    December 11, 2025
    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

    ROOT CAUSE: AFTER A THOROUGH ANALYSIS BY THE BD CURITIBA QUALITY AND PACKAGING TEAM, IT WAS DETERMINED THAT THE ROOT CAUSE OF THE DEFECT IS RELATED TO THE CREATION OF THE LABEL IN THE BD PRINTING SYSTEM CALLED PLZ. DURING THE LABEL REVIEW, THE TEAM RESPONSIBLE FOR REGISTERING THE INFORMATION IN THE PRINTING SYSTEM DID NOT PAY ATTENTION TO THE "TW" INFORMATION, WHICH SHOULD HAVE BEEN REMOVED FROM THE LABEL. ACCORDING TO THE BD DOCUMENT - (B)(4): HYPODERMIC NEEDLE LABELS RELEASED IN SAP, THE LABEL SHOULD NOT DISPLAY EITHER "TW" OR "RW". THEREFORE, THE FAILURE OCCURRED IN TWO MOMENTS: 1. FAILURE TO REMOVE THE "TW" INFORMATION FROM THE PLZ SYSTEM. 2. FAILURE TO DETECT THE "TW" INFORMATION DURING THE LABEL REVIEW AFTER THE CHANGE IN THE PLZ PRINTING SYSTEM. SCOPE: A SURVEY IS BEING CONDUCTED ON SKUS X PRINTING SYSTEM X DESIGN, WHICH CONTAIN NEEDLES, TO VERIFY THE CONDITION OF THE OTHER PRINTS. DEADLINE: 04/11/25. RESPONSIBLE: (B)(4). STATUS: COMPLETED. IMMEDIATE ACTIONS: REMOVAL OF THE "TW" INFORMATION FROM THE PRINTING SYSTEM. DEADLINE: 03/10/2025. RESPONSIBLE: (B)(4). STATUS: COMPLETED. CORRECTIVE ACTIONS: INCLUSION IN THE LABEL REVIEW PROCEDURE SO THAT THE REVIEW OF CHANGES TO BE MADE IN THE PRINTING X LABEL DESIGN IS CARRIED OUT THROUGH CONFIRMATION FROM THE QUALITY AND ENGINEERING AREAS. DEADLINE: 14/11/2025. RESPONSIBLE: (B)(4). STATUS: COMPLETED. TW: INFORMATION ABOUT THE WALL THICKNESS - ¿TW¿ (THIN WALL). PG: DOCUMENT (B)(4) - HYPODERMIC NEEDLE LABELS. PLZ: THE SYSTEM USED TO PRINT THE LABELS. DUE TO THE SEVERITY OF THE DEFECT, THAT IS, BEING A PROBLEM WITH LITTLE IMPACT ON THE CONFORMITY OF THE QUALITY/REGULATORY SYSTEM, WITHOUT ADVERSE HEALTH CONSEQUENCES, THIS MAY RESULT IN INCONVENIENCE FOR THE USER OR PATIENT. LITTLE OR NO SCRAP PRODUCED. NO IMPACT ON CUSTOMER SATISFACTION (FOR SERVICE PROVISION). DISCREPANCY BETWEEN THE SHIPPING BOX LABEL AND THE INMETRO CERTIFICATE. CORRECTION MADE. NO ACTION IS NEEDED ON BATCHES ALREADY PRODUCED, AS THE DISCREPANCY DOES NOT AFFECT PRODUCT CONFORMITY.

    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 INFORMAITON PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE 27X1/2 LL ECLIPSE LABEL CONTENT WAS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ¿WHEN EVALUATING THE PHOTOS OF THE NEEDLES COLLECTED, WE OBSERVED THAT PRODUCT 30281264 (TUV 23.1126) HAS A WALL THICKNESS OF ¿TW¿ (THIN), BUT THE NEEDLE SHOULD BE ¿RW¿ (REGULAR) ACCORDING TO THE CURRENT CERTIFICATE.¿ CUSTOMER NAME: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1018743 BD NEEDLE 27X1/2 LL ECLIPSE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON IND. CIRURGICAS LTDA 5253037

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown