BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE PLASTIPAK 5ML S/SU

    MDR report key: 24932222 · Received April 20, 2026

    Report

    Report Number
    3003916417-2026-00063
    Event Type
    Malfunction
    Date Received
    April 20, 2026
    Date of Event
    February 13, 2026
    Report Date
    April 6, 2026
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMF
    PMA / PMN Number
    N/A
    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 BD EVA-AI3-SM3 SYRINGE PLASTIPAK 5ML S/SU STERILITY WAS QUESTIONED. IT WAS REPORTED THAT 11 UNITS WERE IDENTIFIED WITH THE PACKAGING OPEN. PRODUCT: SERINGA DESC 5ML L LOCK CX 700UN BD REF (B)(4). LOT: 5272973 ; EXPIRY DATE: 30/09/2030. ADDITIONAL INFORMATION RECEIVED ON 15-APR-2026. HAS THERE BEEN ANY DAMAGE TO THE PATIENT'S HEALTH? IF YES, PLEASE EXPLAIN IN DETAIL. NO. WAS THE INCIDENT NOTIFIED TO ANVISA? IF YES, WHAT WAS THE NOTIFICATION NUMBER? YES, NOTIFICATION NUMBER: (B)(4). CAN YOU CONFIRM THE DATE (DD/MM/YYYY) ON WHICH THE PROBLEM/DEFECT OCCURRED OR WAS IDENTIFIED? (B)(6) 2026.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    416699 BD SYRINGE PLASTIPAK 5ML S/SU PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 5272973

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other