BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SAFETYGLIDE

    MDR report key: 23908944 · Received December 29, 2025

    Report

    Report Number
    1213809-2025-00796
    Event Type
    Malfunction
    Date Received
    December 29, 2025
    Date of Event
    December 3, 2025
    Report Date
    January 21, 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
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION THE REPORTED ISSUE WAS A SEPARATION OF THE NEEDLE FROM THE HUB. ONE SAMPLE IN AN OPENED BLISTER PACKAGE WAS RECEIVED AND EVALUATED BY THE QUALITY TEAM. VISUAL INSPECTION FOUND THE NEEDLE ASSEMBLY LACKED THE NEEDLE. THE TOP OF THE NEEDLE HUB HAD EPOXY COVERING APPROXIMATELY 340 DEGREES OF THE ORIFICE. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS CONDITION MAY OCCUR IN THE EVENT OF A CANNULATOR JAM. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 305901, LOT 5080421. ALL IN PROCESS AND FINAL VISUAL INSPECTIONS WERE PERFORMED PER REQUIREMENTS, WITH NO QUALITY NOTIFICATIONS RELATED TO THE REPORTED CONDITION. THE LOT MET ACCEPTANCE CRITERIA PER THE INSPECTION CONTROL PLAN AND WAS RELEASED TO DISTRIBUTION. ADDITIONAL DHRS FOR EACH BATCH OF NEEDLES USED IN MANUFACTURING THIS FINAL LOT WERE ALSO REVIEWED, THERE WAS NO DOCUMENTATION OF THIS DEFECT DURING THE PRODUCTION RUNS. THE CANNULATOR WAS VERIFIED, WITH SETTINGS WITHIN SPECIFICATION AND ACCEPTABLE PRODUCT FLOW. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION, INCLUDING ANALYSIS OF THE RETURNED SAMPLE, THE CUSTOMER REPORTED CONDITION IS CONFIRMED.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. E.1. ADDRESS WAS NOT LOCATED, AND IL WAS USED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD 305901 NEEDLE SFTYGLD 25X5/8 RB NEEDLE PULLED OUT OF HUB. VERBATIM: IT WAS THE BD SAFETYGLIDE NEEDLE REF# 305901 LOT# 5080421. THE NEEDLE WAS INSERTED INTO A VIAL. WHEN THE NEEDLE WAS BEING REMOVED FROM THE VIAL, THE NEEDLE SEPARATED FROM THE HUB. NO PATIENT WAS HARMED. THE NEEDLE WAS PUT IN A SHARPS CONTAINER, BUT WE HAVE RETAINED THE HUB AND PACKAGING FOR INSPECTION IF NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1917069 BD SAFETYGLIDE NEEDLE HYPODERMIC SINGLE LUMEN FMI BECTON DICKINSON MEDICAL SYSTEMS 5080421 00382903059010

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other