BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BD INTEGRA PRECISIONGLIDE

    MDR report key: 23799584 · Received December 14, 2025

    Report

    Report Number
    1213809-2025-00777
    Event Type
    Injury
    Date Received
    December 14, 2025
    Date of Event
    November 27, 2025
    Report Date
    January 26, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    MEG
    UDI-DI
    00382903052707
    PMA / PMN Number
    K011103
    Adverse Event
    Yes
    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

    (B)(4). FOLLOW UP. IT WAS REPORTED THAT THE NEEDLE DETACHED FROM THE SYRINGE. SIX RADIOGRAPHIC IMAGES WERE PROVIDED, EACH DEPICTS BONE WITH A SINGLE RADIOPAQUE FOCUS INDICATED BY AN ARROW. BECAUSE THE PRODUCT INCORPORATES A RETRACTABLE NEEDLE DESIGN WHERE THE METAL CANNULA WITHDRAWS INTO THE INNER PLUNGER ROD FOR SAFETY THE IMAGES ARE INSUFFICIENT TO DETERMINE WHETHER THE OBSERVED RADIOPACITY IS DEVICE RELATED. THE REPORTED CONDITION CANNOT BE CONFIRMED FROM RADIOGRAPHS ALONE. A RETURNED PHYSICAL SAMPLE IS REQUIRED TO CONDUCT A COMPREHENSIVE EVALUATION AND SUPPORT A DEFINITIVE ROOT CAUSE DETERMINATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 305270, LOT 2080949. ALL IN PROCESS AND FINAL VISUAL INSPECTIONS WERE PERFORMED AS REQUIRED, AND NO QUALITY NOTIFICATIONS RELATED TO THE REPORTED CONDITION WERE IDENTIFIED. THE LOT MET ACCEPTANCE CRITERIA PER THE INSPECTION CONTROL PLAN, WAS APPROVED FOR SHIPMENT, AND IS IN COMPLIANCE WITH APPLICABLE PRODUCT SPECIFICATIONS. TO DATE, NO OTHER SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE AVAILABLE INFORMATION AND PHOTO SAMPLE ANALYSIS, THE REPORTED NEEDLE DISCONNECTION COULD NOT BE CONFIRMED.

    Additional Manufacturer Narrative · 0

    E.1. ADDRESS WAS NOT LOCATED AND IL WAS USED. 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

    IT WAS REPORTED THAT THE BD SYRINGE INTEGRA 3ML W/NDL 25X1 RB NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 305270; BATCH#: 2080949. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. I USED A BD INTEGRA SYRINGE TO INJECT A PRESCRIBED HORMONE REPLACEMENT. I HAVE USED THEM SUCCESSFULLY FOR A COUPLE OF YEARS WITHOUT ANY ISSUES UNTIL YESTERDAY. I INJECTED MY HORMONE REPLACEMENT, AND THE NEEDLE DISCONNECTED FROM THE SYRINGE AND SHOT INTO MY LEG. THIS CAUSED A TRIP TO THE EMERGENCY ROOM, AND A CONSULTATION WITH A SURGEON WHO SAID THE NEEDLE IS EMBEDDED TOO DEEP IT THE LEG MUSCLE, TENDONS, NERVES, THAT HE FELT FOR NOW, THE SURGERY TO REMOVE IT WOULD CAUSE MORE HARM AND DAMAGE THEN JUST LEAVING IT IN. IN THE FUTURE A SURGERY MAY BE REQUIRED IF THE NEEDLE CAUSES ANY FURTHER PAIN OR DAMAGE TO THE LEG. I AM EXTREMELY UPSET BY THIS SITUATION, AS I HAVE BEEN USING THESE NEEDLES TO INJECT MY HORMONE REPLACEMENT FOR MANY YEARS WITHOUT INCIDENT. I HAVE INCURRED DISTRESS AND FINANCIAL LOSS DUE TO THIS SITUATION, AND MAY NEED A SURGERY ON THE FUTURE TO REMOVE IT. I AM REQUESTING RESPONSE REGARDING THE ACTIONS THAT BD INTEGRA WILL TAKE TO ENSURE THIS ISSUE DOES NOT HAPPEN TO ANYONE ELSE, AS WELL AS COMPENSATION FOR MY RECENT MEDICAL EXPENSES, INCLUDING MY TRIP THE EMERGENCY ROOM, AND POTENTIAL FUTURE SURGERY. I HAVE RETAINED THE BOTTOM PART OF THE SYRINGE AND HAVE COPIES OF THE X-RAYS CLEARLY SHOWING WHERE THE NEEDED IS EMBEDDED IN MY LEG. THE LOT # ON THE PACKAGE IS 2080949.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2039063 BD INTEGRA PRECISIONGLIDE SYRINGE, ANTISTICK MEG BECTON DICKINSON MEDICAL SYSTEMS 2080949 00382903052707

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Unknown Other