BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 24611606 · Received March 16, 2026

    Report

    Report Number
    1213809-2026-00121
    Event Type
    Malfunction
    Date Received
    March 16, 2026
    Date of Event
    February 20, 2026
    Report Date
    April 2, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096237
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 1ML S/T W/NDL 27X1/2 RB NEEDLE PULLED OUT OF HUB. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. COMPLAINT#: (B)(4). PRODUCT: BD 1ML TB SYRINGE SLIP TIP WITH DETACHABLE PRECISION GLIDE NEEDLE. PRODUCT #: UNKNOWN. LOT NUMBER#: 5042215. COMPLAINT: A REGISTERED NURSE REPORTED VIA EMAIL THAT A BD 1ML TB SYRINGE SLIP TIP WITH BD PRECISION GLIDE NEEDLE DETACHED FROM SYRINGE WHEN USED FOR INTRADERMAL INJECTION LEAVING NEEDLE ON PATIENT'S SKIN.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    111561 BD SAFETYGLIDE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5042215 00382903096237

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other