BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 24444984 · Received February 25, 2026

    Report

    Report Number
    1911916-2026-00085
    Event Type
    Malfunction
    Date Received
    February 25, 2026
    Date of Event
    February 23, 2026
    Report Date
    March 11, 2026
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    00382903052110
    PMA / PMN Number
    K941562
    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)(4) FOLLOW UP. THE CUSTOMER REPORTED THE PRESENCE OF A BLACK SUBSTANCE ON THE NEEDLE. BECAUSE THE PHYSICAL SAMPLE WAS NOT RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE CONDUCTED. TO SUPPORT THE INVESTIGATION, TWO PHOTOGRAPHS WERE PROVIDED FOR REVIEW BY THE QUALITY TEAM. ONE IMAGE DEPICTS THE NEEDLE ASSEMBLY WITHIN THE BLISTER PACKAGING, AND THE SECOND SHOWS THE TOP WEB OF THE BLISTER PACK. NO DEFECTS OR ABNORMALITIES WERE OBSERVED IN EITHER PHOTOGRAPH. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR MATERIAL NUMBER 305211, LOT 4142167. THE REVIEW CONFIRMED THAT NO QUALITY ISSUES WERE DETECTED DURING THE MANUFACTURE OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE IDENTIFIED. ALL PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. ADDITIONALLY, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT TO DATE. BASED ON THE INVESTIGATION AND THE LIMITED PHOTOGRAPHIC EVIDENCE AVAILABLE, THE REPORTED CONDITION COULD NOT BE CONFIRMED. WITHOUT THE ABILITY TO ANALYZE THE ACTUAL PHYSICAL SAMPLE, THE PROBABLE ROOT CAUSE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    E1. ADDRESS INFORMATION WAS NOT PROVIDED; THEREFORE, (B)(6) WAS USED AS THE STATE. H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    A PATIENT REPORTED SHE OBSERVED A BLACK SUBSTANCE ON THE NEEDLE. NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165252 NEEDLE FILTER BLUNT FILL 18X1-1/2 NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL UNKNOWN 00382903052110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown