BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 21559214 · Received March 10, 2025

    Report

    Report Number
    1213809-2025-00176
    Event Type
    Malfunction
    Date Received
    March 10, 2025
    Date of Event
    January 24, 2025
    Report Date
    April 1, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - STOPPER DEFECTIVE / DAMAGED. TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON PHOTOS EVALUATION, IT WAS OBSERVED THAT THE STOPPER JAMMED BETWEEN THE BARREL AND THE PLUNGER ROD. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE STOPPER JAMMED DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3152777. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT, WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH 3152777 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    MATERIAL#: 309628. BATCH#: 3152777. IT WAS REPORTED THAT THE BD LUER-LOK STOPPER WAS DEFECTIVE / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. ON 24JAN2025 XX WAS INFORMED OF AN EVENT WITH EYLEA 8MG VIAL KIT WHICH WAS CATEGORIZED WITH THE DEFECT OTHER. ON 24JAN2025, THE REPORTER, WHO IS THE YY, STATED, ¿I WANTED TO LET YOU KNOW THAT A SYRINGE IN ONE OF OUR EYLEAHD PACKAGES CAME DEFECTIVE. IT WAS RECOGNIZED BY STAFF IMMEDIATELY UPON OPENING AND THEY PULLED ALL NEW SUPPLIES." SYRINGE 1ML. LOT: 3152777. CATALOG: 309628. SAMPLE WAS NOT RETURNED. PLEASE REVIEW WHAT CONTROLS ARE IN PLACE TO ENSURE THE STOPPER IS PROPERLY SEATED AND PROVIDE A BATCH RECORD REVIEW OF THE SYRINGE LOT. ADDITIONAL INFORMATION PROVIDED: YES, THE PROVIDED DATE OF 24JAN2025 IS THE DATE OF EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1254361 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3152777

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown