BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE PRECISIONGLIDE 30X1/2IN

    MDR report key: 23315722 · Received October 16, 2025

    Report

    Report Number
    3003916417-2025-00220
    Event Type
    Malfunction
    Date Received
    October 16, 2025
    Date of Event
    September 25, 2025
    Report Date
    December 17, 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 FOUND 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 - PG 009 4 DGL DOCUMENT: HYPODERMIC NEEDLE LABELS RELEASED IN SAP, THE LABEL SHOULD NOT CONTAIN EITHER "TW" OR "RW". THEREFORE, THE FAILURE OCCURRED IN TWO MOMENTS: 1. FAILURE TO REMOVE THE "TW" INFORMATION IN THE PLZ SYSTEM; 2. FAILURE TO DETECT THE "TW" INFORMATION DURING THE LABEL REVIEW AFTER THE CHANGE IN THE PLZ PRINTING SYSTEM. SCOPE: AN ACTIVITY IS BEING CONDUCTED ON SKUS X PRINTING SYSTEM X DESIGN THAT CONTAIN NEEDLES TO VERIFY THE CONDITION OF OTHER PRINTS. DEADLINE: 04/11/25. RESPONSIBLE: ANDRÉ LAFFITES. STATUS: IN PROGRESS. IMMEDIATE ACTIONS: REMOVAL OF "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: IN PROGRESS. TW: INFORMATION ABOUT THE WALL THICKNESS - ¿TW¿ (THIN WALL). PG: DOCUMENT PG 009 4 DGL - HYPODERMIC NEEDLE LABELS. PLZ: THE SYSTEM USED TO PRINT THE LABELS.

    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

    EXPANDED INVESTIGATION. 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 - PG 009 4 DGL: 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: (B)(6) 2025. RESPONSIBLE: ANDRÉ LAFFITES. STATUS: COMPLETED. IMMEDIATE ACTIONS: REMOVAL OF THE "TW" INFORMATION FROM THE PRINTING SYSTEM. DEADLINE: (B)(6) 2025. RESPONSIBLE: IVAN SILVA. 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: (B)(6) 2025. RESPONSIBLE: IVAN SILVA. STATUS: COMPLETED. TW: INFORMATION ABOUT THE WALL THICKNESS - ¿TW¿ (THIN WALL). PG: DOCUMENT PG 009 4 DGL - 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE PRECISIONGLIDE 30X1/2IN LABEL CONTENT WAS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT WHEN WE EVALUATED THE PHOTOS OF THE NEEDLES COLLECTED, WE NOTICED THAT PRODUCT 990193 (TUV 21.0097=TUV 25.1017) HAS A WALL THICKNESS OF ¿TW¿ (THIN), BUT THE NEEDLE SHOULD BE ¿RW¿ (REGULAR) ACCORDING TO THE CURRENT CERTIFICATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2374483 BD NEEDLE PRECISIONGLIDE 30X1/2IN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON IND. CIRURGICAS LTDA 5150660

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown