BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 22383986 · Received July 2, 2025

    Report

    Report Number
    1911916-2025-00477
    Event Type
    Malfunction
    Date Received
    July 2, 2025
    Date of Event
    May 2, 2025
    Report Date
    July 8, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903096534
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION. A REPORT WAS RECEIVED INDICATING THE PRESENCE OF PARTICULATES WITHIN THE FLUID PATH. TO SUPPORT THE INVESTIGATION, TWO SAMPLES IN SEALED BLISTER PACKAGING AND TWO ACCOMPANYING PHOTOGRAPHS WERE SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. A VISUAL INSPECTION WAS CONDUCTED USING MAGNIFICATION AT 10X AND SUBSEQUENTLY AT 30X. ONE OF THE SAMPLES EXHIBITED A DARK BROWN EMBEDDED SPECK LOCATED ON A RIB OF THE PLUNGER ROD. THE SECOND SAMPLE SHOWED NO VISIBLE DEFECTS OR IRREGULARITIES. THE SUBMITTED PHOTOGRAPHS CORRESPOND TO THE RECEIVED SAMPLES. THE OBSERVED EMBEDDED PARTICULATE IS CONSISTENT WITH DEGRADED RESIN, WHICH CAN OCCUR DURING THE STARTUP PHASE OR INTERMITTENTLY THROUGHOUT THE INJECTION MOLDING PROCESS. DURING THESE PERIODS, DEGRADED RESIN MAY DISLODGE AND BECOME INCORPORATED INTO MOLDED COMPONENTS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS COMPLETED FOR MATERIAL NUMBER 309653, LOT 5003529. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES OR DEVIATIONS DURING PRODUCTION THAT COULD BE LINKED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND, AND ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. ADDITIONALLY, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT TO DATE. BASED ON THE ANALYSIS OF THE RETURNED SAMPLES, THE CUSTOMER-REPORTED CONDITION HAS BEEN CONFIRMED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED BY CUSTOMER THAT THEY IDENTIFIED A CRITICAL DEFT INVOLVING 2 PARTICULATES INSIDE FLUID PAT IN 2 UNITS DURING INSPECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    177517 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 5003529 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown