BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE PRECISIONGLIDE 16X1-1/2IN

    MDR report key: 24088966 · Received January 15, 2026

    Report

    Report Number
    3003916417-2026-00010
    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 WAS NOTED TO HAVE DAMAGED PACKAGING. VERBATIM: BEING: NEEDLE 1.60X40MM (16GX1 1/2''), QUANTITY: 9, LOT: 4120571, NF: (B)(6), REASON: 1 UNIT WITH GELATINOUS FOREIGN BODY INSIDE THE PROTECTIVE COVER, 1 DEFORMATION IN THE BEVEL, 6 DIRTY AROUND THE PACKAGING AND INSIDE THE NEEDLE. BATCH: 2363754, QUANTITY: 12, NF: (B)(6), REASON: 1 DEFORMED OR BROKEN PLASTIC, 9 WITH DIRT ON THE NEEDLE, 2 HOLES IN THE PACKAGING. BATCH: 3264804, QUANTITY: 8, NF: (B)(6), REASON: 6 WITH DIRT ON THE NEEDLE, 2 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, 1 DEFORMATION IN THE BEVEL, 6 DIRTY AROUND THE PACKAGING AND INSIDE THE NEEDLE (1+1+6=8)" BUT QUANTITY MENTIONED AS 9. COULD YOU PLEASE CONFIRM THE AFFECTED QUANTITY OF THE BATCH NUMBER 4120571? A: 2 HOLES OUTSIDE THE PACKAGING; 1 DEFORMED BEVEL; 6 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
    37374 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