BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 30ML LL BNS

    MDR report key: 23295104 · Received October 15, 2025

    Report

    Report Number
    1911916-2025-00678
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    August 26, 2025
    Report Date
    October 1, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903010332
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT THE SYRINGE CRACKED DURING SAMPLE EXTRACTION FROM THE SOURCE BOTTLE. TO SUPPORT THE INVESTIGATION, ONE UNPACKAGED SAMPLE WAS SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. A VISUAL INSPECTION REVEALED A CRACK IN THE SYRINGE BARREL, BEGINNING APPROXIMATELY 5/8" FROM THE BOTTOM AND EXTENDING 2" IN LENGTH. NO ADDITIONAL DEFECTS OR IMPERFECTIONS WERE OBSERVED. THIS TYPE OF DAMAGE MAY OCCUR IF A JAM IS ENCOUNTERED DURING THE ASSEMBLY PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED FOR MATERIAL NUMBER 301033, LOT 3110643. 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. VERIFICATION OF THE ASSEMBLY PROCESS CONFIRMED THAT EQUIPMENT SETTINGS, RAIL AND CONVEYOR ALIGNMENT, AND PRODUCT FLOW WERE ALL WITHIN ACCEPTABLE PARAMETERS. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLE, THE REPORTED ISSUE 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 30ML LL BNS BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #301033, LOT #3110643. VERBATIM: RCC RECEIVED A COMPLAINT VIA COMMUNITY. THIS WOULD HAVE CAUSED A LEAK AND CONTAMINATION IF NOT CAUGHT AND SEALED BEFORE IT CONTACTED FLUID. THE DUAL 30ML SYRINGE ASSEMBLY WAS BEING USED TO PULL A SAMPLE. WHEN PULLING THE SAMPLE FROM THE SOURCE BOTTLE, THE SYRINGE CRACKED. THE CRACK OCCURRED ABOVE THE PLUNGER, SO NO SAMPLE LEAKED OUT. THE OPERATOR CLAMPED THE LINE AND THE MANIFOLD WAS WELDED OFF PAST THE WELD THAT CONNECTED IT TO THE BOTTLE. IT WAS NOT CRACKED PRIOR TO SAMPLING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2018927 BD SYRINGE 30ML LL BNS PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 3110643 00382903010332

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown