BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE PRECISIONGLIDE 21X1IN

    MDR report key: 24094588 · Received January 16, 2026

    Report

    Report Number
    3003916417-2026-00019
    Event Type
    Malfunction
    Date Received
    January 16, 2026
    Date of Event
    May 5, 2025
    Report Date
    April 29, 2026
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    UDI-DI
    30000078909794
    PMA / PMN Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PACKAGE DAMAGED / DEFECTIVE / OTHER A DETAILED ANALYSIS OF THE LOT HISTORY (DHR) WAS PERFORMED, ALONG WITH A REVIEW OF ALL QUALITY NOTIFICATIONS, PRODUCTION RECORDS, AND MAINTENANCE RECORDS ASSOCIATED WITH THE LOT IN QUESTION. NO PRIOR RECORDS OR DEVIATIONS RELATED TO THE REPORTED DEFECT WERE IDENTIFIED. FOR THE DEFECT CLASSIFIED AS PACKAGE DAMAGED / DEFECTIVE / OTHER, THE COMPLAINT WAS NOT CONFIRMED. THE RECEIVED SAMPLE WAS SUBJECTED TO THE CARBON TEST, IN ACCORDANCE WITH THE APPLICABLE PROCEDURE, AND NO PERFORATION OR LOSS OF PACKAGE INTEGRITY WAS IDENTIFIED, AS EVIDENCED BY THE ATTACHED TEST REPORT. TEAR IN THE PACKAGING A METICULOUS ANALYSIS OF THE LOT HISTORY (DHR) WAS CONDUCTED, AND ALL PRODUCTION, MAINTENANCE, AND QUALITY NOTIFICATION RECORDS ASSOCIATED WITH THIS LOT WERE REVIEWED. NO DEVIATIONS OR NONCONFORMITIES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS. THE RECEIVED SAMPLE WAS EVALUATED, AND THE TEAR OBSERVED IN THE PACKAGING IS CONSISTENT WITH DAMAGE CAUSED DURING THE BLISTER SEPARATION PROCESS. WHEN THIS PROCEDURE IS PERFORMED INCORRECTLY, IT MAY RESULT IN MECHANICAL TEARING OF THE PACKAGING, WHICH IS NOT RELATED TO THE MANUFACTURING OR SEALING PROCESS. BASED ON THIS ANALYSIS, BD DOES NOT CONFIRM THE COMPLAINT. CONCLUSION BASED ON THE AVAILABLE INFORMATION AND THE ANALYSES PERFORMED, THE VALIDITY OF THE COMPLAINT CANNOT BE CONFIRMED. THE MANUFACTURING PROCESS IS VALIDATED ACCORDING TO PREDEFINED ACCEPTANCE CRITERIA AND COMPLIES WITH APPLICABLE QUALITY REQUIREMENTS. THE REPORTED INCIDENT WILL BE CONTINUOUSLY MONITORED FOR TREND EVALUATION PURPOSES. AS THIS OCCURRENCE DOES NOT EXCEED THE ACCEPTABLE QUALITY LIMIT (AQL) OF THE LOT, NO ADDITIONAL CORRECTIVE OR PREVENTIVE ACTIONS ARE PROPOSED AT THIS TIME.

    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 PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD EVA-AI3-SM3 NEEDLE PRECISIONGLIDE 21X1IN PACKAGE WAS DAMAGED. BATCH: 5031737 QUANTITY: (B)(4) REASON: 5 DIRTY IN THE PACKAGING AND INSIDE THE NEEDLE, 2 EXTENSIONS IN THE PROTECTIVE COVER PIERCING THE PACKAGING, 1 DEFORMATION IN THE BEVEL, 1 BROKEN, 1 TEAR IN THE PACKAGING BATCH: 4173465 QUANTITY: (B)(4) REASON: 2 INTERNAL DIRT. BATCH: 4204356 QUANTITY: (B)(4) REASON: 3 FOREIGN BODIES INSIDE THE NEEDLE, 2 DIRT INSIDE THE NEEDLE, 2 BROKEN CANNONS, 1 TEAR IN THE PACKAGING. ADDITIONAL INFORMATION RECEIVED ON 02 JAN 2026 BASED ON THE ANALYSIS OF THE PHOTOS YOU PROVIDED, WE IDENTIFIED THE NEW BATCH NUMBER (B)(6) WITH THREE ASSOCIATED PHOTOS. COULD YOU CONFIRM FROM WHICH DISTRIBUTOR THIS BATCH WAS PURCHASED? (B)(6) - CM HOSPITALAR MAFRA NF: (B)(4) - 3 UNITS DIRTY IT WAS A BATCH WITHOUT INCLUDING WAS THE INCIDENT REPORTED TO ANVISA? IF SO, WHAT IS THE NOTIFICATION NUMBER? NO, ONLY THE COMPANY. COULD YOU CONFIRM THE DATE ON WHICH THE PROBLEM/DEFECT OCCURRED OR WAS IDENTIFIED? (B)(6) 2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442705 BD NEEDLE PRECISIONGLIDE 21X1IN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON IND. CIRURGICAS LTDA 5031737 30000078909794

    Patients

    Seq Age Sex Outcome Treatment
    1