BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 23734933 · Received December 5, 2025

    Report

    Report Number
    1911916-2025-00779
    Event Type
    Malfunction
    Date Received
    December 5, 2025
    Date of Event
    September 3, 2025
    Report Date
    December 10, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    00382903051809
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. WITH NO ACTUAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.

    Additional Manufacturer Narrative · 0

    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

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE 18X1-1/2 BLUNT FILL WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305180 BATCH # 5002107. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I HAVE BEEN LOOPED INTO A PREVIOUS PRODUCT FAILURE REGARDING A BD BLUNT NEEDLE. THE NEEDLE FROM THIS INCIDENT WAS NOT SAVED. MY APOLOGIES FOR THE LATE SUBMISSION. LET ME KNOW IF THERE ARE ANY ADDITIONAL QUESTIONS. DATE OF INCIDENT: (B)(6) 2025. LOCATION: INCIDENT: ¿RN WAS DRAWING UP NAROPIN, AND THE BLUNT TIP NEEDLE BROKE OFF IN THE VIAL. BD BLUNT FILL NEEDLE REF # 305180, 18G X 1 1/2 TW, LOT 5002107¿ DEVICE DETAILS: REF # 305180 LOT 5002107.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2883880 BD NEEDLE 18X1-1/2 BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 5002107 00382903051809

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown