BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 23796836 · Received December 12, 2025

    Report

    Report Number
    1911916-2025-00793
    Event Type
    Malfunction
    Date Received
    December 12, 2025
    Date of Event
    November 18, 2025
    Report Date
    December 12, 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
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT AN INCORRECT LOT NUMBER APPEARED ON THE DISPENSER BOXES. TO SUPPORT THE INVESTIGATION, THREE PHOTOGRAPHS WERE PROVIDED FOR EVALUATION BY THE QUALITY TEAM. THE FIRST PHOTOGRAPH SHOWS A PACKAGING CASE BOX LABEL WITH LOT NUMBER 5213846, THE SECOND SHOWS AN INDIVIDUAL BLISTER PACKAGE WITH THE SAME LOT NUMBER, AND THE THIRD DISPLAYS A SHELF BOX LABEL WITH LOT NUMBER 5029287. THIS DISCREPANCY COULD OCCUR IF THE WRONG LOT NUMBER WAS APPLIED TO THE SHELF BOX LABEL. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR MATERIAL NUMBER 305180, LOT 5213846. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND, AND ALL PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. ASSOCIATES HAVE BEEN INFORMED OF THIS EVENT. TO DATE, NO SIMILAR OCCURRENCES HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE PHOTOGRAPHIC EVIDENCE, THE CUSTOMER¿S REPORTED ISSUE HAS BEEN CONFIRMED. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE 18X1-1/2 BLUNT FILL LABEL CONTENT WAS INCORRECT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305180 LOT # UNKNOWN VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. BUSSE ITEM # 1593A ¿ (18G X 1.50 STERILE BLUNT NEEDLE) BD ITEM # 305180 LOT # 5213845 PO 92179 QTY RECEIVED/REJECTED: 6 CASES (B)(4) PCS) DATE RECEIVED: 11/17/2025. REASON OF REJECTION: INCORRECT LOT NUMBER ON THE DISPENSER BOXES ¿ SEE PHOTO ATTACHED. DURING OUR INCOMING INSPECTION, OUR QA INSPECTOR NOTED A DISCREPANCY BETWEEN THE LOT NUMBERS: THE SHIPPER CARTON AND UNIT ARE LABELED LOT # 5213846, WHILE THE DISPENSER BOXES ARE LABELED LOT # 5029287.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2762185 BD NEEDLE 18X1-1/2 BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 5213846 00382903051809

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown