BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD NEEDLE FILTER 19X1-1/2 TW

    MDR report key: 23700957 · Received December 2, 2025

    Report

    Report Number
    1911916-2025-00775
    Event Type
    Malfunction
    Date Received
    December 2, 2025
    Date of Event
    November 7, 2025
    Report Date
    December 17, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    GAA
    UDI-DI
    00382903052004
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THAT BLACK SPECKS WERE OBSERVED ON THE NEEDLE AND HUB. TO SUPPORT THE INVESTIGATION, ONE SAMPLE WITHOUT PACKAGING AND THREE PHOTOGRAPHS WERE PROVIDED FOR EVALUATION BY THE QUALITY TEAM. A VISUAL INSPECTION CONFIRMED THAT THE PLASTIC SHIELD CONTAINED DARK-COLORED SPECKS OF EMBEDDED DEGRADED RESIN AT THE BOTTOM. THE PHOTOGRAPHS CORRESPONDED TO THE SAMPLE RECEIVED, AND NO ADDITIONAL DEFECTS OR IMPERFECTIONS WERE IDENTIFIED. THE PRESENCE OF DEGRADED RESIN IN THE COMPONENT TYPICALLY OCCURS DURING STARTUP OR INTERMITTENTLY THROUGHOUT THE INJECTION MOLDING PROCESS, WHEN DEGRADED MATERIAL CAN BREAK LOOSE AND BECOME INCORPORATED INTO MOLDED PARTS. A REVIEW OF THE DEVICE HISTORY RECORD FOR MATERIAL NUMBER 305200, LOT 2172517, REVEALED NO DETECTED QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE IDENTIFIED, AND ALL PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN COMPLIANCE WITH SPECIFICATION REQUIREMENTS. THE SAMPLE WILL BE SHARED WITH ASSOCIATES FOR AWARENESS. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLE, THE CUSTOMER¿S REPORTED OBSERVATION HAS BEEN CONFIRMED.

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT BLACK SPECKS WERE OBSERVED ON THE TOP OF THE SYRINGE. TO SUPPORT THE INVESTIGATION, ONE SAMPLE WITHOUT PACKAGING AND THREE PHOTOGRAPHS WERE PROVIDED FOR EVALUATION BY THE QUALITY TEAM. A VISUAL INSPECTION CONFIRMED THAT THE PLASTIC SHIELD CONTAINED DARK-COLORED SPECKS OF EMBEDDED DEGRADED RESIN AT THE BOTTOM. THE PHOTOGRAPHS CORRESPONDED TO THE SAMPLE RECEIVED, AND NO ADDITIONAL DEFECTS OR IMPERFECTIONS WERE IDENTIFIED. THE PRESENCE OF DEGRADED RESIN IN THE COMPONENT TYPICALLY OCCURS DURING STARTUP OR INTERMITTENTLY THROUGHOUT THE INJECTION MOLDING PROCESS, WHEN DEGRADED MATERIAL CAN BREAK LOOSE AND BECOME INCORPORATED INTO MOLDED PARTS. A REVIEW OF THE DEVICE HISTORY RECORD FOR MATERIAL NUMBER 305200, LOT 2172517, REVEALED NO DETECTED QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE IDENTIFIED, AND ALL PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN COMPLIANCE WITH SPECIFICATION REQUIREMENTS. THE SAMPLE WILL BE SHARED WITH ASSOCIATES FOR AWARENESS. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLE, THE CUSTOMER¿S REPORTED OBSERVATION 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 FILTER 19X1-1/2 TW HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305200, BATCH # 2172517. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. "BLACK SPECKS ON THE TOP OF THE SYRINGE WITH THE PRODUCT, AFTER THE MEDICATION WAS DRAWN FROM THE VIAL" LOT# 2172517. NEW INFORMATION PROVIDED: "SPECKS WERE OBSERVED IN BOTH SYRINGE AND IN NEEDLE (BD SYRINGE LOT # 3034733, BD NEEDLE LOT # 2172517"

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2849587 BD NEEDLE FILTER 19X1-1/2 TW NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE GAA BD MEDICAL (BD WEST) MEDICAL SURGICAL 2172517 00382903052004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown