BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 23797868 · Received December 13, 2025

    Report

    Report Number
    1213809-2025-00768
    Event Type
    Malfunction
    Date Received
    December 13, 2025
    Date of Event
    October 23, 2025
    Report Date
    January 14, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903059164
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED, A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED, AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION. THE COMPLAINT WAS NOT CONFIRMED, AND NO CAPA EVALUATION WAS REQUIRED. THIS COMPLAINT TYPE WILL CONTINUE TO BE TRENDED WITHIN THE POST-MARKET SURVEILLANCE PROCESS, AND ANY DETERMINED ESCALATION WILL BE MANAGED THERE.

    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 THE BD NEEDLE SFTYGLD 25X1 RB HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305916 BATCH#: 5022041 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED AFTER VACCINE WAS ADMINISTERED, THEN NEEDLE OF THE SYRINGE DETACHED FROM THE SYRINGE AND STAYED IN THE PATIENTS ARM AFTER THE SYRINGE WAS REMOVED. THE NEEDLE ITSELF WAS THEN SAFELY REMOVE FROM THE PATIENT'S ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2710104 BD SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 5022041 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown