BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE PRECISIONGLIDE 21X1IN

    MDR report key: 24094606 · Received January 16, 2026

    Report

    Report Number
    3003916417-2026-00020
    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

    FM ¿ FOREIGN MATTER ON NEEDLE AN ANALYSIS OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED, ALONG WITH A REVIEW OF ASSOCIATED QUALITY NOTIFICATIONS; NO RECORDS PREVIOUSLY RELATED TO THIS DEFECT WERE IDENTIFIED. REGARDING THE FOREIGN MATTER DEFECT, THE SAMPLES AND PHOTOS PROVIDED BY THE CUSTOMER WERE EVALUATED, CONFIRMING THE REPORTED INCIDENT. DURING THE EVALUATION, THE PRESENCE OF DEBRIS ON THE NEEDLE¿ORIGINATING FROM STAGES OF THE ASSEMBLY PROCESS¿WAS OBSERVED. ACCORDINGLY, BD CONFIRMS AND REPRODUCES THE COMPLAINT. NO MAINTENANCE ORDERS OR QUALITY NOTIFICATIONS RELATED TO THIS INCIDENT WERE IDENTIFIED. ALTHOUGH THE PRESENCE OF DEBRIS ON THE NEEDLE WAS CONFIRMED, IT WAS NOT POSSIBLE TO IDENTIFY THE NATURE OF THE MATERIAL OR DETERMINE THE ROOT CAUSE OF ITS OCCURRENCE. THE PRODUCTION PROCESS INCORPORATES A QUANTITATIVE INSPECTION ROUTINE AIMED AT MAINTAINING A STATISTICAL BASIS FOR MATERIAL RELEASE. THE NEEDLES UNDERGO VISUAL AND FUNCTIONAL INSPECTIONS DESIGNED TO CONTAIN POTENTIAL DEFECTS PRIOR TO MARKET RELEASE. NO DEFECTS WERE IDENTIFIED DURING THE PRODUCTION OF THE EVALUATED LOT. GIVEN THAT THIS PROCESS REQUIRES OPERATIONAL VIGILANCE, THE INVOLVED EMPLOYEES WILL BE NOTIFIED. ADDITIONALLY, AS THIS IS THE FIRST COMPLAINT RECORDED FOR THIS LOT AND IT DOES NOT EXCEED THE ACCEPTABLE QUALITY NOTIFICATION (AQN) LIMIT, THE INCIDENT WILL BE MONITORED FOR TREND ANALYSIS.

    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 CONTAINED FOREIGN MATTER. 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 4120787 WITH THREE ASSOCIATED PHOTOS. COULD YOU CONFIRM FROM WHICH DISTRIBUTOR THIS BATCH WAS PURCHASED? 4120787 - 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
    424947 BD NEEDLE PRECISIONGLIDE 21X1IN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON IND. CIRURGICAS LTDA 4120787 30000078909794

    Patients

    Seq Age Sex Outcome Treatment
    1