BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD CONVENTIONAL NEEDLES

    MDR report key: 22593980 · Received July 24, 2025

    Report

    Report Number
    3002682307-2025-00092
    Event Type
    Malfunction
    Date Received
    July 24, 2025
    Date of Event
    June 16, 2025
    Report Date
    August 11, 2025
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 300400 AND LOT NUMBER 241006. THE REVIEW DID NOT REVEAL ANY ABNORMALITIES DETECTED DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. TO AID IN THE INVESTIGATION OF THIS ISSUE, TWO (2) PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THROUGH EXAMINATION OF THE PICTURES, A NEEDLE WITH SOME DROP IN THE HUB SURFACE WAS OBSERVED. WE CAN CONCLUDE THAT THE NEEDLE LEAKS FROM THE HUB SURFACE BASED ON THE PICTURE. BASED ON THE PICTURE SAMPLE FINDINGS, THIS ISSUE COULD POTENTIALLY BE RELATED TO A MOLDING DEFECT DURING THE MANUFACTURING PROCESS. BASED ON THE PREVENTIVE MEASURES IN PLACE, WE BELIEVE THE PROBABILITY OF THIS DEFECT IS VERY LOW WITH AN UNLIKELY CHANCE OF RECURRENCE. THIS IS THE FIRST REPORT RECEIVED FOR THIS TYPE OF DEFECT ON MATERIAL 300400 AND LOT 241006. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: EVENT DATE CLARIFIED. E/F CODES UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD CONVENTIONAL NEEDLES; NEEDLE HUB HAS A HOLE AND LEAKES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING INJECTION FOR A SENTINEL LYMPH NODE EXAMINATION, ONE OF THE ORANGE CANULAS WAS PIERCED AT ITS CATHETER ADAPTER, THE PRODUCT THEREFORE CAME OUT OF THE HOLE AND NOT THE CANULA, CAUSING THE RADIOACTIVE PRODUCT TO SPREAD OVER THE PATIENT'S BREAST INSTEAD OF BEING INJECTED SUBCUTANEOUSLY.

    Description of Event or Problem · 0

    THU (B)(6) 2025 4:28 AM. HAS THE PATIENT OR USER BEEN HARMED? YES MINIMAL, RADIOACTIVE PRODUCT SPREAD ON THE PATIENT'S SKIN INSTEAD OF BEING ADMINISTERED SUBCUTANEOUSLY - SKIN CONTAMINATION - DECONTAMINATION AND OK. COULD YOU SPECIFY THE DATE OF THE EVENT? 16/06/2025. AS YOU MENTIONED IN YOUR REPORT, YOU HAVE ENCOUNTERED THIS SHORTCOMING AGAIN. COULD YOU CONFIRM THE TOTAL NUMBER OF INCIDENTS IDENTIFIED WITH THE SAME DEFECT AND WHEN THEY OCCURRED? PROBLEM ENCOUNTERED ONLY ONCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1637962 BD CONVENTIONAL NEEDLES NEEDLES, HYPODERMIC FMI BECTON DICKINSON, S.A. 241006

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown