BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL S/C 56

    MDR report key: 22507152 · Received July 15, 2025

    Report

    Report Number
    1911916-2025-00516
    Event Type
    Malfunction
    Date Received
    July 15, 2025
    Date of Event
    July 3, 2025
    Report Date
    July 31, 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

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION. A CUSTOMER REPORTED THE PRESENCE OF WHITE FILAMENTS WITHIN THE RUBBER COMPONENT OF THE PRODUCT. TO SUPPORT THE INVESTIGATION, ONE SAMPLE IN AN OPENED BLISTER PACKAGE AND TWO ACCOMPANYING PHOTOGRAPHS WERE SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. VISUAL INSPECTION REVEALED PLASTIC PARTICLES ON THE UPPER PORTION OF THE RUBBER STOPPER AND BETWEEN THE STOPPER RIBS. ADDITIONALLY, DAMAGE WAS OBSERVED AT THE TOP OF THE SYRINGE BARREL NEAR THE RETAINING RING. THE TWO PHOTOGRAPHS PROVIDED CORRESPOND TO THE RECEIVED SAMPLE. NO OTHER DEFECTS OR IRREGULARITIES WERE IDENTIFIED. THIS CONDITION IS CONSISTENT WITH DAMAGE TO THE RETAINING RING DURING THE ASSEMBLY OF THE PLUNGER ROD INTO THE SYRINGE BARREL. A REVIEW OF THE DEVICE HISTORY RECORD FOR MATERIAL NUMBER 302832, LOT 4152407, WAS CONDUCTED. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE COMPLETED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. THE SAMPLE WILL BE USED FOR ASSOCIATE AWARENESS. TO DATE, NO ADDITIONAL SIMILAR COMPLAINTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLE, 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. THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD.

    Description of Event or Problem · 0

    EVENT DETAILS: WE OPENED A STERILE 30 ML BD LUER-LOCK SYRINGE LOT: 4152407 EXPIRATION 20290531 AND THERE WERE WHITE FILAMENTS INSIDE THE RUBBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1534378 SYRINGE 30ML LL S/C 56 SYRINGE, PISTON FMF BECTON DICKINSON 4152407 00382903028320

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown