BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 50ML LL TIP 1ML

    MDR report key: 23139482 · Received September 24, 2025

    Report

    Report Number
    1911916-2025-00654
    Event Type
    Malfunction
    Date Received
    September 24, 2025
    Date of Event
    September 9, 2025
    Report Date
    September 16, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. IT WAS REPORTED THAT THE TIP OF A 50 ML LUER-LOK SYRINGE BROKE DURING REMOVAL FROM A LARGE BORE STOPCOCK EQUIPPED WITH A ROTATING MALE LUER LOCK. TO SUPPORT THE INVESTIGATION, ONE SYRINGE SAMPLE IN OPENED BLISTER PACKAGING, ALONG WITH A BAXTER-BRANDED STOPCOCK, WAS SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. UPON VISUAL INSPECTION, THE SYRINGE BARREL'S LUER TIP WAS FOUND TO BE BROKEN OFF. NO ADDITIONAL DEFECTS OR ABNORMALITIES WERE OBSERVED. PREVIOUS INVESTIGATIONS HAVE INDICATED THAT EXCESSIVE TORQUE APPLIED DURING ASSEMBLY OF THE SYRINGE TO A STOPCOCK CAN RESULT IN LUER TIP BREAKAGE. A REVIEW OF THE DEVICE HISTORY RECORD FOR MATERIAL NUMBER: 309653, LOT: 5142417, 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 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 50ML LL TIP 1ML LUER WAS CRACKED / DAMAGED / DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309653, BATCH#: 5142417. RCC RECEIVED A COMPLAINT VIA EMAIL. WDH EXPERIENCED AN ISSUE WITH REF: 309653, LOT: 5142417 BD 50ML SYRINGE. NURSING REPORTS: "WHILE PERFORMING THERAPEUTIC PHLEBOTOMY VIA VAD, WHEN NURSING REMOVED A 50ML LUER LOCK SYRINGE FROM LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK(BARD) THE TIP OF THE LUER LOCK OF THE 50ML SYRINGE HAD SEVERED/BROKEN. NURSING REMOVED ALL EQUIPMENT FROM PATIENT. ATTACHED SYRINGE DIRECTLY TO VAD ASPIRATED/DISCARDED 10ML BLOOD AND FLUSHED VAD WITHOUT INCIDENT. NO INJURY TO PATIENT." THE PRODUCT AND ITS PACKAGING IS AVAILABLE FOR RETURN FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2430884 BD SYRINGE 50ML LL TIP 1ML PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 5142417

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown