BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 18027025 · Received October 29, 2023

    Report

    Report Number
    1213809-2023-01191
    Event Type
    Malfunction
    Date Received
    October 29, 2023
    Date of Event
    October 5, 2023
    Report Date
    February 3, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095774
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4) - FOLLOW UP MDR FOR DEVICE EVALUATION. IT WAS REPORTED ONE OF THE SYRINGES SNAPPED IN HALF. TO AID IN THE INVESTIGATION, ELEVEN SAMPLES OF 3ML LUER LOK SYRINGES FROM LOT 3003985 WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. TEN OF THE SAMPLES WERE IN SEALED PACKAGING BLISTERS WITH ALL APPLICABLE PRODUCT INFORMATION ON THE TOP WEB. THERE WERE NO DEFECTS OBSERVED ON THESE TEN SAMPLES. ONE SAMPLE WAS RECEIVED LOOSE AND HAS A CRACK IN THE BARREL EXTENDING 1 1/8" FROM THE ZERO LINE DOWN TOWARDS THE 2ML GRADUATION LINE. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION AND IS ASSOCIATED WITH THE ASSEMBLY PROCESS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309577, LOT 3003985. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. LOT 3003985 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN, SUBSEQUENTLY APPROVED FOR SHIPMENT AND IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS. THIS CONDITION IS OCCURRING AT OR BELOW ITS EXPECTED FREQUENCY; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK SYRINGE WAS DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILE DOING A PROCEDURE, ONE OF THE SYRINGES SNAPPED IN HALF." PHYSICIAN CONTINUED PROCEDURE USING ANOTHER SYRINGE.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2139370 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3003985 30382903095774

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown