BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE 18X1-1/2 BLUNT FILL

    MDR report key: 23772606 · Received December 10, 2025

    Report

    Report Number
    1911916-2025-00786
    Event Type
    Malfunction
    Date Received
    December 10, 2025
    Date of Event
    November 19, 2025
    Report Date
    November 25, 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
    MI, 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 THERE WAS WHITE BUILDUP ON THE NEEDLE. OUR QUALITY TEAM HAS COMPLETED A DEVICE HISTORY RECORD REVIEW FOR MATERIAL NUMBER 305180 AND LOT NUMBER 5092742. THE REVIEW DID NOT IDENTIFY ANY ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE DEFECT, AND ALL QUALITY TESTS WERE WITHIN SPECIFICATION. DUE TO THE UNAVAILABILITY OF A SAMPLE FOR RETURN, A COMPREHENSIVE SAMPLE INVESTIGATION COULD NOT BE CONDUCTED. CONSEQUENTLY, THE EXACT CAUSE OF THIS INCIDENT REMAINS UNDETERMINED. AT THIS TIME, NO FURTHER ACTION IS DEEMED NECESSARY. COMPLAINTS RELATED TO THIS DEVICE AND THE REPORTED CONDITION WILL CONTINUE TO BE MONITORED AND ANALYZED FOR EMERGING TRENDS BY OUR QUALITY TEAM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD NEEDLE 18X1-1/2 BLUNT FILL HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #305180 LOT #5092742 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL.TOOK BD BLUNT FILL NEEDLE OUT OF PACKAGING AND FOUND WHITE BUILDUP ON NEEDLE PRIOR TO USE. PRODUCT WORKDAY ITM-NUMBER: ITM-1092552, LOT NUMBER: 5092742, SUPPLIER & SUPPLIER REFERENCE/RE-ORDER OR ITEM NUMBER: BD REF: 305180 EXPIRATION DATE: 2030-05-31.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1858912 BD NEEDLE 18X1-1/2 BLUNT FILL NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 5092742 00382903051809

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown