BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE PLASTIPAK 10ML S/SU

    MDR report key: 25307140 · Received May 27, 2026

    Report

    Report Number
    3003916417-2026-00079
    Event Type
    Malfunction
    Date Received
    May 27, 2026
    Date of Event
    May 14, 2026
    Report Date
    May 19, 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
    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 SYRINGE PLASTIPAK 10ML S/SU CONTAINED FOREIGN MATTER. IT WAS OBSERVED THAT THE SYRINGE HAS CONTAMINATION INSIDE - POSSIBLE PRESENCE OF MOLD. THE PACKAGE IS SEALED. MATERIAL: HYPODERMIC SYRINGE WITHOUT NEEDLE. REFERENCE: 990172. BATCH: 6071496 / FAB: 2026-03. AFFECTED QUANTITY: 1 UNIT. PHOTO SUBMITTED: YES. VIDEO UPLOADED: YES. SAMPLE FOR COLLECTION: YES. ANVISA NOTIFICATION: YES, UNDER NO. 2026.05.002637.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    198270 BD SYRINGE PLASTIPAK 10ML S/SU PISTON SYRINGE FMF BECTON DICKINSON IND. CIRURGICAS LTDA 6071496

    Patients

    Seq Age Sex Outcome Treatment
    1