BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETYGLIDE

    MDR report key: 23892566 · Received December 25, 2025

    Report

    Report Number
    2243072-2025-01540
    Event Type
    Malfunction
    Date Received
    December 25, 2025
    Date of Event
    December 3, 2025
    Report Date
    December 8, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMI
    UDI-DI
    00382903059164
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INVESTIGATION AND WITH THE SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. PROBABLE ROOT CAUSE. IT COULD BE POSSIBLE THAT WHEN THE HINGE WAS ASSEMBLED INTO THE NEEDLE HUB IT WAS PUSHED DOWN TOO LOW INDUCING THE SYMPTOM REPORTED BY THE CUSTOMER AND NOT DETECTED IN THE NEXT PROCESSES. VERIFICATION OF THE HINGE ASSEMBLY STATION WAS PERFORMED. SETTINGS WERE CORRECT. POSITION OF THE HINGE IN THE NEEDLE HUB WAS CORRECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD NEEDLE SFTYGLD 25X1 RB SAFETY MECHANISM BROKE IT WAS REPORTED BY CUSTOMER THAT THE SAFETY BROKE OFF COMPLETELY, LEAVING EXPOSED NEEDLE RCC RECEIVED A COMPLAINT VIA EMAIL. INCIDENT OR PROBLEM INFORMATION MDIP REFERENCE NUMBER (ID): 11858 DATES OF INCIDENT (YYYY-MM-DD): (B)(6) 2025 TYPE OF INCIDENT/PROBLEM: A2. FAILURE (I.E. WHILE PREPARING FOR, IN USE, AFTER USE) LEVEL OF HARM: OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): INCIDENT DETAILS: I IMMUNIZED CLIENT, ATTEMPTED TO FLIP SAFETY ON SYRINGE. SAFETY BROKE OFF COMPLETELY, LEAVING EXPOSED NEEDLE. I WAS ABLE TO GET EXPOSED NEEDLE SAFELY TO SHARPS BIN WITHOUT INCIDENT. IMPACT OF INCIDENT: WHO WAS AFFECTED? UNEXPECTED OR PROLONGED CARE? YES DEVICE INFORMATION DEVICE NAME/DESCRIPTION: NEEDLE HYPODERMIC SAFETY 25GA X 1 IN MANUFACTURER: BECTON DICKINSON CANADA INC MANUFACTURER CODE/MODEL: 305916 SERIAL OR LOT NUMBER: (B)(6) EXPIRY DATE: 2027-09-30 SUPPLIER: (B)(4)/CATALOGUE NUMBER: 308-305916 IS THE DEVICE RETAINED? YES NUMBER OF DEVICES: 1 WIPED, CONTAINED, LABELLED? UNKNOWN DEVICE HANDLING HAZARDS (WHEN BLANK = HAZARDS NOT SPECIFIED).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2318827 SAFETYGLIDE HYPODERMIC SINGLE LUMEN NEEDLE FMI BECTON DICKINSON REGX0369 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown