BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE PRECISIONGLIDE 16X1-1/2IN

    MDR report key: 24089582 · Received January 15, 2026

    Report

    Report Number
    3003916417-2026-00014
    Event Type
    Malfunction
    Date Received
    January 15, 2026
    Date of Event
    May 5, 2025
    Report Date
    May 4, 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD EVA-SI3-SM3 NEEDLE PRECISIONGLIDE 16X1-1/2IN CONTAINED FOREIGN MATTER. VERBATIM: BEING: NEEDLE 1.60X40MM (16GX1 1/2''), QUANTITY: (B)(4), LOT: 4120571, NF: 1144357. REASON: (B)(4) UNIT WITH GELATINOUS FOREIGN BODY INSIDE THE PROTECTIVE COVER, (B)(4) DEFORMATION IN THE BEVEL, (B)(4) DIRTY AROUND THE PACKAGING AND INSIDE THE NEEDLE. BATCH: 2363754, QUANTITY: (B)(4), NF: 1039693, REASON: (B)(4) DEFORMED OR BROKEN PLASTIC, (B)(4) WITH DIRT ON THE NEEDLE, (B)(4) HOLES IN THE PACKAGING. BATCH: 3264804, QUANTITY: (B)(4), NF: 1067682, REASON: (B)(4) WITH DIRT ON THE NEEDLE, (B)(4) TEARS IN THE PACKAGING. ADDITIONAL INFORMATION RECEIVED ON 01/02/2026 IT WAS MENTIONED AS "1 UNIT WITH GELATINOUS FOREIGN BODY INSIDE THE PROTECTIVE COVER, (B)(4) DEFORMATION IN THE BEVEL, (B)(4) DIRTY AROUND THE PACKAGING AND INSIDE THE NEEDLE (B)(4)" BUT QUANTITY MENTIONED AS (B)(4). COULD YOU PLEASE CONFIRM THE AFFECTED QUANTITY OF THE BATCH NUMBER 4120571? A: 2 HOLES OUTSIDE THE PACKAGING; (B)(4), DEFORMED BEVEL; (B)(4), DIRTY AREAS AROUND AND INSIDE THE PACKAGING. 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 TO THE COMPANY. IS THE SAMPLE RELATED TO THIS INCIDENT AVAILABLE FOR ANALYSIS? IF YES PLEASE ANSWER THE BELOW QUESTIONS A: YES

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303660 BD NEEDLE PRECISIONGLIDE 16X1-1/2IN NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON IND. CIRURGICAS LTDA 3264804 50000078909729

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other