BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE

    MDR report key: 24691897 · Received March 25, 2026

    Report

    Report Number
    3003916417-2026-00051
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    February 11, 2026
    Report Date
    March 11, 2026
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST
    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 THE BD SYRINGE PLASTIPAK 3ML S/SU HAD LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE PRODUCT IS NOT HOLDING PRESSURE AND IS LEAKING MEDICATION THROUGH THE PLUNGER. PURCHASE INVOICES: NO. (B)(4), NF: (B)(4), QUANTITY: (B)(4). ADDITIONAL INFORMATION RECEIVED ON 16-MAR-2026: COULD YOU CONFIRM HOW MANY UNITS OF THE PRODUCT EXHIBITED THE PROBLEM/DEFECT? (B)(4) UNITS WHEN WAS THE PROBLEM/DEFECT IDENTIFIED: BEFORE, DURING, OR AFTER USE? DURING/AFTER USE WAS THERE ANY HARM TO THE PATIENT¿S HEALTH? IF YES, PLEASE EXPLAIN IN DETAIL. NO. WAS THE INCIDENT REPORTED TO ANVISA? IF YES, WHAT IS THE NOTIFICATION NUMBER? NO. CAN YOU CONFIRM THE DATE (DD/MM/YYYY) ON WHICH THE PROBLEM/DEFECT OCCURRED OR WAS IDENTIFIED? 02/11/2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477265 BD SYRINGE PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 5058821

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown