BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 23961149 · Received January 5, 2026

    Report

    Report Number
    1911916-2026-00001
    Event Type
    Malfunction
    Date Received
    January 5, 2026
    Date of Event
    December 12, 2025
    Report Date
    January 5, 2026
    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
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. IT WAS REPORTED THAT THE OUTER CASE DISPLAYED ONE LOT NUMBER WHILE THE SHELF BOXES INSIDE THE CASE DISPLAYED A DIFFERENT LOT NUMBER. TO SUPPORT THE INVESTIGATION, TWO PHOTOGRAPHS WERE EVALUATED BY OUR QUALITY TEAM. ONE IMAGE SHOWS THE CASE PACKAGING LABEL INDICATING LOT 5213846, AND THE OTHER SHOWS A SHELF BOX LABEL INDICATING LOT 5029287. THIS DISCREPANCY COULD OCCUR IF THE INCORRECT LOT NUMBER WAS ENTERED ON THE SHELF BOX LABEL DURING PRODUCTION OF LOT 5213846. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 305180, LOT 5213846. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. THERE WERE NO RELATED QUALITY NOTIFICATIONS, AND ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. ASSOCIATES HAVE BEEN MADE AWARE OF THIS EVENT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE PROVIDED PHOTOGRAPHS, THE CUSTOMER¿S REPORTED CONDITION IS 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, BATCH # 5213846. VERBATIM: "MY ACCOUNT RECEIVED 2 CASES OF NEEDLES THAT HAD INCONSISTENT LOT NUMBERS ON THEM. THE CASE HAD ONE LOT NUMBER, BUT THE BOXES INSIDE THE CASE HAD A DIFFERENT LOT NUMBER. THIS IS FOR A RESEARCH STUDY GROUP AND THEY NEED TO HAVE EVERYTHING DOCUMENTED PROPERLY AND LOT NUMBERS NEED TO MATCH. I TALKED TO OUR CUSTOMER SERVICE TEAM AND THE PRODUCT WASN¿T OPENED AT A MCKESSON WAREHOUSE, I THEN SPOKE TO BD CUSTOMER SUPPORT AND HE WASN¿T SURE WHY THE CASE HAD A DIFFERENT LOT NUMBER THAN THE BOXES. THEY ARE REQUESTING A QUALITY RESPONSE FROM BD ON THE PACKAGING ISSUE. IS THAT SOMETHING YOU CAN PROVIDE? PLEASE SEE BELOW. OUR QUALITY CONTROL DEPARTMENT HAS RAISED AN INVESTIGATION REGARDING THE MIXED LOTS ON OUR ORDER (B)(4). 20 PACKS OF C10034497 - NEEDLE BLUNT FILL 18G X 1-1/2" STERILE BD 305180 SUPPLIED IN COMMERCIAL PACK X 100 NEEDLES (UOM=COMMERCIAL PACK). OUR QC DEPARTMENT FOUND: WHILE INSPECTING THE COMMERCIAL PACKS, IT WAS NOTICED THE LOT ON THE COMMERCIAL PACKAGING 5029287 IS NOT THE SAME AS THE LOT ON THE SUPPLIER LABEL OR MATERIAL 5213846. ALL 20 COMMERCIAL PACKAGES HAVE THE INCORRECT LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    19166 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