BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD PLASTIPAK HYPODERMIC SYRINGE WITH NEEDLE

    MDR report key: 24327453 · Received February 12, 2026

    Report

    Report Number
    3003916417-2026-00029
    Event Type
    Malfunction
    Date Received
    February 12, 2026
    Date of Event
    January 12, 2026
    Report Date
    February 13, 2026
    Manufacturer
    BECTON DICKINSON IND. CIRURGICAS LTDA
    Product Code
    FMI
    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

    INVESTIGATION RESULTS: THE REPORTED DEFECT COULD NOT BE REFUTED NOR CONFIRMED IN THE ABSENCE OF A SAMPLE. THE ROOT CAUSE CANNOT BE DETERMINED FOR AN UNCONFIRMED DEFECT. A COMPLAINT HISTORY (CHR) REVIEW COULD NOT BE PERFORMED AS NO BATCH/LOT AND MATERIAL NUMBER WAS MADE AVAILABLE FOR THIS REPORTED EVENT. A DEVICE HISTORY RECORD (DHR) REVIEW COULD NOT BE PERFORMED AS NO BATCH/LOT AND MATERIAL NUMBER WAS MADE AVAILABLE FOR THIS REPORTED EVENT. A REVIEW OF THE APPLICABLE RISK DOCUMENT INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY IN THE RISK MANAGEMENT DOCUMENTATION.

    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

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD PLASTIPAK HYPODERMIC SYRINGE WITH NEEDLE, THE NEEDLE WENT THROUGH THE SHIELD. VERBATIM: "UPON OPENING THE PACKAGE OF THE BD BRAND TUBERCULIN SYRINGE - LOT: 150380 - EXP: 06/2025, IT WAS OBSERVED THAT THE NEEDLE GUARD HAD BEEN DAMAGED BY THE NEEDLE ITSELF".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15240 BD PLASTIPAK HYPODERMIC SYRINGE WITH NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON IND. CIRURGICAS LTDA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other