BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 23069602 · Received September 16, 2025

    Report

    Report Number
    1911916-2025-00641
    Event Type
    Malfunction
    Date Received
    September 16, 2025
    Date of Event
    July 20, 2025
    Report Date
    September 24, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    UDI-DI
    00382903096534
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP IT WAS REPORTED A PARTICLE WAS FOUND IN THE HEAT SEAL PORTION OF THE BD 50ML SYRINGE. OUR QUALITY TEAM HAS COMPLETED A DEVICE HISTORY RECORD REVIEW FOR MATERIAL NUMBER 309653 AND LOT NUMBER 5092551. THE REVIEW DID NOT IDENTIFY ANY ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE DEFECT, AND ALL QUALITY TESTS WERE WITHIN SPECIFICATION. DUE TO THE UNAVAILABILITY OF A SAMPLE FOR RETURN, A COMPREHENSIVE SAMPLE INVESTIGATION COULD NOT BE CONDUCTED. CONSEQUENTLY, THE EXACT CAUSE OF THIS INCIDENT REMAINS UNDETERMINED. SHOULD YOU ENCOUNTER ANY FURTHER ISSUES WITH OUR PRODUCT, WE WOULD APPRECIATE THE OPPORTUNITY TO PERFORM A DETAILED ANALYSIS. AT THIS TIME, NO FURTHER ACTION IS DEEMED NECESSARY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 50ML LL TIP 1ML HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #309653, LOT #5092551. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PARTICLE WAS FOUND IN HEAT SEAL PORTION OF BD 50 ML SYRINGE. LOT NUMBER: 5092551, EXPIRATION: 03/31/2030, REF: 309653.

    Description of Event or Problem · 0

    IN THE MEDSUN FORM MENTIONED THAT THE DATE OF THE EVENT AS JUL-2025. COULD YOU PLEASE SPECIFY THE EXACT DATE WHEN THE REPORTED ISSUE HAPPENED? 7/20/2025.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1730967 BD LUER-LOK PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 5092551 00382903096534

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown