BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL TIP 1ML

    MDR report key: 22644385 · Received July 29, 2025

    Report

    Report Number
    1911916-2025-00545
    Event Type
    Malfunction
    Date Received
    July 29, 2025
    Date of Event
    July 23, 2025
    Report Date
    August 8, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903096534
    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 REPORT WAS RECEIVED INDICATING THE PRESENCE OF AN EXTRANEOUS PIECE OF PLASTIC ON THE LUER LOCK TIP OF A SYRINGE. TO SUPPORT THE INVESTIGATION, ONE SAMPLE¿INCLUDING THE PACKAGING BLISTER TOP WEB¿WAS SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. UPON VISUAL INSPECTION, A MOLDING FLASH APPROXIMATELY 1/16" IN LENGTH WAS OBSERVED ON THE SYRINGE BARREL LUER TIP. NO ADDITIONAL DEFECTS OR IRREGULARITIES WERE IDENTIFIED. THIS CONDITION CAN OCCUR DURING THE MOLDING PROCESS IF THERE IS A DELAY IN PART EJECTION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR MATERIAL NUMBER 309653, LOT 5142409. THE REVIEW FOUND NO QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE IDENTIFIED. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. THE MOLDING PROCESS PARAMETERS WERE VERIFIED AND FOUND TO BE WITHIN SPECIFICATION, WITH NO FLASH OBSERVED ON PARTS DURING PRODUCTION. THE RETURNED SAMPLE WILL BE SHARED WITH PRODUCTION ASSOCIATES TO RAISE AWARENESS. TO DATE, NO SIMILAR EVENTS 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.

    Description of Event or Problem · 0

    IT IS REPORTED FOREIGN MATTER. EVENT DETAILS: MATERIAL#: 309653, BATCH#: 5142409. ¿ON (B)(6) 2025, WHILE MIXING INSIDE THE CLEAN ROOM, WE FOUND 1 BD SYRINGE 50CC REF#: 309653, LOT#: 5142409, EXPIRY DATE: 2030/04/30 WITH AN EXTRA PIECE OF PLASTIC ON THE LUER LOCK TIP OF THE SYRINGE.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    887567 SYRINGE 50ML LL TIP 1ML SYRINGE, PISTON FMF BECTON DICKINSON 5142409 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown