BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE

    MDR report key: 25171032 · Received May 14, 2026

    Report

    Report Number
    3002682307-2026-00063
    Event Type
    Malfunction
    Date Received
    May 14, 2026
    Date of Event
    May 5, 2026
    Report Date
    May 7, 2026
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMI
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    003

    Narratives

    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

    IT WAS REPORTED THAT THE BD NEEDLE 27GA 3/4IN PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT WHILE ADMINISTERING THE INJECTION, THE NEEDLE (LOT: 220336, EXP 02/2027) BROKE OFF FROM THE SYRINGE WHILE IT WAS INSIDE HER ABDOMEN. SHE IMMEDIATELY NOTICED DROPS OF MEDICATION LEAKING ONTO HER SKIN, AND THE NEEDLE HAD FULLY DETACHED FROM THE SYRINGE. FORTUNATELY, SHE WAS ABLE TO GRASP THE TIP AND REMOVE IT. SHE STATED THAT THIS IS EXTREMELY CONCERNING AND POSES A SIGNIFICANT SAFETY RISK.¿ OUR PACKAGING ENGINEER HAS PERFORMED AN INITIAL INVESTIGATION THE RECEIVED SAMPLE. THE FINDINGS ARE SUMMARIZED BELOW; PICTURES OF THE SAMPLE ARE ATTACHED. INITIAL INVESTIGATION: OBSERVATIONS: NEEDLE HUB: THE NEEDLE ENTRY POINT OF THE HUB APPEARS TO BE SLIGHTLY DAMAGED. NEEDLE: AN UNKNOWN WHITE, STICKY SUBSTANCE IS PRESENT HALFWAY ALONG THE NEEDLE SHAFT. CONCLUSION IT IS LIKELY THAT THE NEEDLE WAS NOT PROPERLY SECURED IN THE NEEDLE HUB AND BECAME DETACHED DURING ADMINISTRATION OF THE MEDICATION. MATERIAL DETAILS: MATERIAL NUMBER: 1011987, BATCH/LOT NUMBER: 220336, SAMPLE AVAILABILITY: A SAMPLE IS AVAILABLE FOR INVESTIGATION. COMPLAINT HANDLING REQUEST: PLEASE CONFIRM RECEIPT OF THIS COMPLAINT BY RETURN EMAIL. KINDLY INITIATE AN INVESTIGATION INTO THIS ISSUE. PLEASE PROVIDE THE INVESTIGATION REPORT, INCLUDING ROOT CAUSE ANALYSIS AND PROPOSED CAPAS, NO LATER THAN 29 MAY 2026. WE HAVE RECEIVED A MARKET COMPLAINT REGARDING A NEEDLE THAT DETACHED FROM THE HUB DURING USE AND WOULD LIKE TO FORMALLY INFORM YOU OF THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    246736 BD NEEDLE NEEDLE, HYPODERMIC, SINGLE LUMEN FMI BECTON DICKINSON, S.A. 220336

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown