BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 50ML LL TIP 1ML

    MDR report key: 23262740 · Received October 9, 2025

    Report

    Report Number
    1911916-2025-00676
    Event Type
    Malfunction
    Date Received
    October 9, 2025
    Date of Event
    September 17, 2025
    Report Date
    September 25, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A BROWN RESIDUE WAS REPORTED INSIDE A SYRINGE. TO SUPPORT THE INVESTIGATION, ONE SAMPLE¿INCLUDING TWO PACKAGING BLISTERS¿AND TWO PHOTOGRAPHS WERE SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. UPON VISUAL INSPECTION, THREE DARK BROWN SPECKS OF EMBEDDED DEGRADED RESIN WERE OBSERVED WITHIN THE SYRINGE BARREL. THE PHOTOGRAPHS PROVIDED CORRESPOND TO THE SAMPLE RECEIVED. NO ADDITIONAL DEFECTS OR ABNORMALITIES WERE NOTED. THE PRESENCE OF EMBEDDED DEGRADED RESIN IS TYPICALLY ASSOCIATED WITH STARTUP CONDITIONS OR INTERMITTENT OCCURRENCES DURING THE INJECTION MOLDING PROCESS. DURING THESE TIMES, DEGRADED RESIN MAY DETACH AND BECOME INCORPORATED INTO MOLDED COMPONENTS. A REVIEW OF THE DEVICE HISTORY RECORD FOR MATERIAL NUMBER 309653, LOT 5171906, WAS CONDUCTED. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLE, THE CUSTOMER-REPORTED CONDITION 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 SYRINGE 50ML LL TIP 1ML HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #309653 LOT #5171906   VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED A 50ML LL SYRINGE OPENED BY TECHNICIAN FOUND BROWN RESIDUE INSIDE THE SYRINGE LOT - 5171906,309653.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    310865 BD SYRINGE 50ML LL TIP 1ML PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 5171906

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown