BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SAFETYGLIDE

    MDR report key: 22537920 · Received July 17, 2025

    Report

    Report Number
    1213809-2025-00483
    Event Type
    Malfunction
    Date Received
    July 17, 2025
    Date of Event
    July 9, 2025
    Report Date
    August 21, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903059010
    PMA / PMN Number
    K951254
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4)- SUPPLEMENTAL MDR - FOREIGN MATTER. ONE SAMPLE AND ONE PHOTO WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE SAMPLE WAS RECEIVED IN AN OPENED BLISTER PACKAGE. UPON VISUAL INSPECTION UNDER 10X MAGNIFICATION, THE SAFETY MECHANISM EXHIBITED RESIDUES CONSISTENT WITH EQUIPMENT LUBRICANT AND SHOWED PHYSICAL MARKINGS INDICATIVE OF THE NEEDLE BECOMING JAMMED DURING ACTIVATION. THE ACCOMPANYING PHOTO DOCUMENTS THE CONDITION OF THE RECEIVED SAMPLE. THE PROBABLE ROOT CAUSE MAY BE A JAM THAT OCCURRED DURING MANUFACTURING AND WAS NOT DETECTED DURING SUBSEQUENT PROCESSING STEPS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 5120220. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    B.3. 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.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE SFTYGLD 25X5/8 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305901. BATCH # 5120220. VERBATIM: SUBSTANCE IN THE SAFETY GLIDE NEEDLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808460 SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 5120220 00382903059010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown