BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETYGLIDE

    MDR report key: 24145440 · Received January 22, 2026

    Report

    Report Number
    1213809-2026-00021
    Event Type
    Malfunction
    Date Received
    January 22, 2026
    Date of Event
    December 31, 2025
    Report Date
    February 3, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903059034
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - NEEDLE PULLED OUT OF HUB. ONE PHOTO OF A 1 ML LUER LOK SYRINGE WITH A 25 X 5/8" SAFETYGLIDE NEEDLE (PART NUMBER 305903, BATCH 5122689) WAS RECEIVED AND REVIEWED. THE IMAGE SHOWS A LOOSE SYRINGE WITH THE SAFETYGLIDE NEEDLE UNATTACHED, PLACED NEXT TO THE TOP WEB SLIP CONTAINING ALL REQUIRED PRODUCT INFORMATION. THE REPORTED DEFECT COULD NOT BE CONFIRMED FROM THE PHOTO PROVIDED, AND THE CONDITION OBSERVED IS ACCEPTABLE PER PRODUCT SPECIFICATIONS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 305903, LOT 5122689. ALL IN PROCESS AND FINAL VISUAL INSPECTIONS WERE PERFORMED AS REQUIRED, AND NO QUALITY NOTIFICATIONS RELATED TO THE REPORTED CONDITION WERE IDENTIFIED. THE LOT MET ACCEPTANCE CRITERIA PER THE INSPECTION CONTROL PLAN, WAS APPROVED FOR SHIPMENT, AND COMPLIES WITH APPLICABLE PRODUCT SPECIFICATIONS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED IN TREND REPORTS AND MONITORED MONTHLY, AND OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA TO IDENTIFY ANY EMERGING TRENDS.

    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 WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 1ML S/T W/NDL SFTYGLD 25X5/8 RB NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 305903, BATCH#: 5122689, 305903, 5122689. ONE OF OUR ICU NURSES WAS ADMINISTERING HEPARIN USING A BD SAFETY GLIDE. ONCE SHE GAVE THE HEPARIN AND WAS ATTEMPTING TO ENGAGE THE SAFETY, THE NEEDLE PORTION FLEW OFF OF THE SYRINGE AND THEN PUNCTURED HER ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147749 SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 5122689 00382903059034

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown