BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD BD NEEDLE FILTER BLUNT FILL 18X1-1/2

    MDR report key: 23403713 · Received October 28, 2025

    Report

    Report Number
    1911916-2025-00699
    Event Type
    Malfunction
    Date Received
    October 28, 2025
    Date of Event
    September 8, 2025
    Report Date
    October 14, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    00382903052110
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A REPORT WAS RECEIVED INDICATING THE PRESENCE OF A HAIR-LIKE FIBER ON THE NEEDLE. AS THE PHYSICAL SAMPLE WAS NOT RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE CONDUCTED. TO SUPPORT THE INVESTIGATION, ONE PHOTOGRAPH WAS PROVIDED AND REVIEWED BY THE QUALITY TEAM. THE IMAGE DEPICTS A NEEDLE ASSEMBLY WITHOUT A PLASTIC SHIELD, WITH A FIBER-LIKE FOREIGN MATERIAL VISIBLE NEAR THE BASE OF THE NEEDLE. NO ADDITIONAL DEFECTS OR IRREGULARITIES WERE OBSERVED. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR MATERIAL NUMBER: 305211, LOT: 4031348. THIS REVIEW FOUND NO QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD BE LINKED TO THE REPORTED CONDITION. ADDITIONALLY, THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND THE ANALYSIS OF THE PHOTOGRAPH, THE CUSTOMER-REPORTED CONDITION IS CONFIRMED. HOWEVER, DUE TO THE ABSENCE OF THE PHYSICAL SAMPLE, A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. 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 FILTER BLUNT FILL 18X1-1/2 HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL: 305211, BATCH#: 4031348. RCC RECEIVED A COMPLAINT VIA EMAIL. (B)(4). ON (B)(6) 2025, XX WAS INFORMED OF AN EVENT WITH EYLEA 8MG VIAL KIT WHICH WAS CATEGORIZED WITH THE DEFECT FOREIGN MATTER ¿ FM FILTER NEEDLE ON (B)(6) 2025, THE OFFICE STAFF REPORTED THE FOLLOWING: ¿AFTER SHE DREW THE MEDICATION OUT FROM THE VIAL, SHE NOTICED THERE WAS A HAIR-LIKE FIBER ON THE NEEDLE. SHE IS UNSURE IF THE FIBER COULD BE PLASTIC OR ANOTHER MATERIAL.¿ FILTER NEEDLE: CATALOG: 305211, LOT: 4031348.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703973 BD BD NEEDLE FILTER BLUNT FILL 18X1-1/2 NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 4031348 00382903052110

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown