BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 23676898 · Received November 29, 2025

    Report

    Report Number
    1213809-2025-00750
    Event Type
    Malfunction
    Date Received
    November 29, 2025
    Date of Event
    November 7, 2025
    Report Date
    December 10, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMI
    UDI-DI
    00382903059164
    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

    PR 13523262 FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THAT PAINT WAS PRESENT ON THE ORANGE HUB OF THE NEEDLE. TO SUPPORT THE INVESTIGATION, FORTY-TWO SAMPLES AND TWO PHOTOGRAPHS WERE SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. FORTY-ONE SAMPLES WERE RECEIVED IN SEALED BLISTER PACKAGING, WHILE ONE SAMPLE ARRIVED IN AN OPENED BLISTER PACKAGE. A VISUAL INSPECTION WAS CONDUCTED, AND THE SAMPLE FROM THE OPENED BLISTER DISPLAYED DARK-COLORED EMBEDDED SPECKS WITHIN THE NEEDLE HUB. THE TWO PHOTOGRAPHS PROVIDED DEPICTED ONE OF THE SAMPLES RECEIVED. NO ADDITIONAL DEFECTS OR IMPERFECTIONS WERE OBSERVED. THE EMBEDDED DEGRADED RESIN IN THE COMPONENT IS TYPICALLY ASSOCIATED WITH STARTUP OR INTERMITTENT OCCURRENCES DURING THE INJECTION MOLDING PROCESS. THIS DEGRADED RESIN CAN BREAK LOOSE AND BECOME INCORPORATED INTO MOLDED COMPONENTS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR MATERIAL NUMBER 305916, LOT 5212180. THE REVIEW CONFIRMED THAT ALL VISUAL INSPECTIONS WERE COMPLETED IN ACCORDANCE WITH REQUIREMENTS, AND NO QUALITY NOTIFICATIONS RELATED TO THE REPORTED CONDITION WERE IDENTIFIED. THE LOT WAS INSPECTED AND ACCEPTED BASED ON THE INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. ADDITIONAL DEVICE HISTORY RECORDS WERE REVIEWED FOR EACH BATCH OF NEEDLES USED IN MANUFACTURING THIS FINAL BATCH. NO DOCUMENTATION INDICATED THE PRESENCE OF THIS TYPE OF DEFECT DURING THE ENTIRE PRODUCTION RUN. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLE, THE CUSTOMER-REPORTED CONDITION HAS BEEN CONFIRMED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE SFTYGLD 25X1 RB HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305916. BATCH # 5212180. RCC RECEIVED A COMPLAINT VIA EMAIL. HEY GUY, I'M NOT SURE HOW I GO ABOUT REPORTING THIS. ONE OF MY NURSES OPENED UP A 25G 1IN NEEDLE TO USE AND FOUND THIS ON IT. NOT SURE IF THIS MEANS THE LOT HAS TO BE THROWN OUT OR WHAT WE SHOULD DO. WAS HOPING YOU COULD HELP DIRECT. PRODUCT IN QUESTION IS 305916, LOT 5212180. CAN YOU ADVISE ON NEXT STEPS? THE PRODUCT HAS BEEN SEQUESTERED AND RETAINED, AS FAR AS I KNOW. ONE OF OUR NURSES FOUND WHAT LOOKS TO BE PAINT ON THE INNER ORANGE HUB OF NEEDLE. DATE OF EVENT WAS ON 11/7/25. ATTACHED IS THE LOT NUMBER AND THE NEEDLE. ADDRESS: (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2801863 BD SAFETYGLIDE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 5212180 00382903059164

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown