BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE PRECISIONGLIDE 16X1-1/2IN

    MDR report key: 24088976 · Received January 15, 2026

    Report

    Report Number
    3003916417-2026-00007
    Event Type
    Malfunction
    Date Received
    January 15, 2026
    Date of Event
    May 5, 2025
    Report Date
    May 1, 2026
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    UDI-DI
    50000078909729
    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

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD EVA-AI3-SM3 NEEDLE PRECISIONGLIDE 18X1-1/2IN WAS NOTED TO HAVE DAMAGED PACKAGING. VERBATIM: BATCH: 3118861 QUANTITIES: 1 NF:1039693 REASON: 1 DIRT OR FOREIGN BODY IN THE NEEDLE. BATCH: 3264352 QUANTITIES: 1 NF:1067682 REASON: 1 EXTENSION IN THE PROTECTIVE COVER PIERCING THE PACKAGING. ADDITIONAL INFORMATION RECEIVED ON 01/02/2026. FOR BATCH 3118861: COULD YOU PLEASE CONFIRM THE DATE OF EVENT? A: 05/05/2025. WAS ANVISA NOTIFIED? IF YES, WHAT WAS THE NOTIFICATION NUMBER? A: NO, ONLY THE COMPANY. IS THE SAMPLE RELATED TO THIS INCIDENT AVAILABLE FOR ANALYSIS? IF YES PLEASE ANSWER THE BELOW QUESTIONS A: YES. FOR BATCH 3264352: COULD YOU PLEASE CONFIRM THE DATE OF EVENT? A: 05/05/2025. WAS ANVISA NOTIFIED? IF YES, WHAT WAS THE NOTIFICATION NUMBER? A: NO, ONLY THE COMPANY. IS THE SAMPLE RELATED TO THIS INCIDENT AVAILABLE FOR ANALYSIS? IF YES PLEASE ANSWER THE BELOW QUESTIONS. A: YES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303659 BD NEEDLE PRECISIONGLIDE 16X1-1/2IN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON IND. CIRURGICAS LTDA 3264352 50000078909729

    Patients

    Seq Age Sex Outcome Treatment
    1