BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL S/C 56

    MDR report key: 22438821 · Received July 8, 2025

    Report

    Report Number
    1911916-2025-00509
    Event Type
    Malfunction
    Date Received
    July 8, 2025
    Date of Event
    June 25, 2025
    Report Date
    July 24, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903028320
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11 -A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION A REPORT WAS RECEIVED REGARDING THE PRESENCE OF SPOTS INSIDE SEVERAL 30ML SYRINGE PACKAGES. TO SUPPORT THE INVESTIGATION, FOUR SEALED BLISTER-PACKAGED SAMPLES AND THREE PHOTOGRAPHS WERE SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. UPON VISUAL INSPECTION, DUST WAS OBSERVED BETWEEN THE TOP AND BOTTOM WEBS OF THE PACKAGING. THE PHOTOGRAPHS CORRESPOND TO THE SAMPLES RECEIVED. NO ADDITIONAL DEFECTS OR ABNORMALITIES WERE NOTED. THIS CONDITION MAY OCCUR IF DUST PARTICLES ARE NOT ADEQUATELY REMOVED FOLLOWING EQUIPMENT MAINTENANCE OR REPAIR. THE SAMPLES WERE FORWARDED TO A LABORATORY FOR FURTHER ANALYSIS. THE LAB REPORT CONFIRMED THE ABSENCE OF MOLD AND IDENTIFIED THE FOREIGN MATERIAL AS MOST CLOSELY RESEMBLING ERUCAMIDE¿A SUBSTANCE NOT UTILIZED IN THE MANUFACTURING PROCESS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR MATERIAL NUMBER 302832, LOT 5031595. THE REVIEW DID NOT REVEAL ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND, AND ALL PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLES, THE CONDITION REPORTED BY THE CUSTOMER HAS BEEN CONFIRMED.

    Description of Event or Problem · 0

    EVENT DETAILS: WE HAVE DISCOVERED SPOTS INSIDE SOME 30ML SYRINGE PACKAGES THAT STRANGELY RESEMBLE MOLD. I HAVE 2 STRIPS OF 4 SYRINGES CONCERNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2072619 SYRINGE 30ML LL S/C 56 SYRINGE, PISTON FMF BECTON DICKINSON 5031595 00382903028320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown