BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 24470141 · Received February 27, 2026

    Report

    Report Number
    1213809-2026-00097
    Event Type
    Malfunction
    Date Received
    February 27, 2026
    Date of Event
    January 5, 2026
    Report Date
    March 10, 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
    PA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: (H) ATTACHED MEDWATCH. INVESTIGATION RESULTS: BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. WITH NO ACTUAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    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 NEEDLE SFTYGLD 25X1 RB NEEDLE PULLED OUT OF HUB. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NEEDLE DETACHED FROM SYRINGE AND REMAINED IN PATIENTS ARM. REMOVED INTACT NEEDLE WITHOUT DIFFICULTY. BD SAFETY GLIDE NEEDLE 25 GAUGE X 1INCH TW, LOT# 5233985, EXPIRATION 07/31/2030, REFERENCE # (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51007 BD SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 5233985 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1