BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 24693911 · Received March 25, 2026

    Report

    Report Number
    1213809-2026-00157
    Event Type
    Malfunction
    Date Received
    March 25, 2026
    Date of Event
    March 5, 2026
    Report Date
    April 15, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903059010
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    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.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP. ONE PHOTOGRAPH WAS REVIEWED SHOWING A NEEDLE ASSEMBLY ATTACHED TO A SYRINGE, WITH NO NEEDLE PRESENT, AND THE PROXIMAL PORTION OF THE NEEDLE ASSEMBLY INSERTED INTO A VIAL STOPPER. BASED ON THE INVESTIGATION AND EVALUATION OF THE PHOTO PROVIDED, THE REPORTED SYMPTOM IS CONFIRMED. HOWEVER, BECAUSE NO PHYSICAL SAMPLE WAS AVAILABLE FOR ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR THE PROVIDED LOT NUMBER 5080421. THE REVIEW IDENTIFIED NO REJECTED INSPECTIONS OR PRODUCTION QUALITY ISSUES THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE SFTYGLD 25X5/8 RB NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #305901 BATCH #5080421 VERBATIM: STAFF WAS TRYING TO MIX DILUENT WITH VACCINE AND THE NEEDLE CAME COMPLETELY OUT OF THE SAFETY GLIDE NEEDLE AND WAS STUCK IN THE DILUENT VIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269394 BD SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 5080421 00382903059010

    Patients

    Seq Age Sex Outcome Treatment
    1