BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 20518907 · Received October 23, 2024

    Report

    Report Number
    9614033-2024-00069
    Event Type
    Malfunction
    Date Received
    October 23, 2024
    Date of Event
    September 27, 2024
    Report Date
    February 5, 2025
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    30382903096047
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D.4. OTHER LOT NUMBER INCLUDES 3233231 AND OTHER EXPIRATION DATE INCLUDES 2028-08-31. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. OTHER LOT NUMBER DEVICE MANUFACTURE DATE IS 2023-09-22.

    Additional Manufacturer Narrative · 0

    FORTY-NINE SAMPLES FROM MATERIAL 309604 BATCH 3233231 AND 2326607 RECEIVED FOR INVESTIGATION. THROUGH VISUAL INSPECTION, LUER IS DAMAGE ON ONE SYRINGE. FUNCTIONAL TESTING IS PERFORMED ON SAMPLES RECEIVED, LEAK OCCURRED ON 22 SYRINGES. LUE DIAMETER WAS MEASURED, DIMENSIONS ARE OUT OF SPECIFICATION. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. POSSIBLE ROOT CAUSE IS ASSOCIATED WITH THE MOLD TEMPERATURE IN THE INJECTION PROCESS. MANUFACTURING PERSONNEL WILL BE NOTIFIED AND ADDITIONAL TRAINING TO REINFORCE PROPER ASSEMBLY WILL BE PERFORMED. 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 HAD LEAKAGE AT THE LUER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER TRANSLATED FROM JAPANESE TO ENGLISH: DURING LIPOSUCTION SURGERY, CUSTOMER CONNECTED A CANNULA (MADE BY COLEMAN) TO THIS SYRINGE AND ASPIRATED, BUT THE FAT WOULD NOT ASPIRATE. THEY SUSPECTED THAT THE CAUSE OF THE FAT NOT ASPIRATING WAS A LEAK IN THE CONNECTION, SO THEY APPLIED GEL AROUND THE CONNECTION (TO FILL THE LEAK PART), AND WHEN THEY ASPIRATED AGAIN, THEY ARE ABLE TO ASPIRATE. CUSTOMER WOULD LIKE US TO INVESTIGATE THE PRODUCT FOR ANY LEAKS.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1425714 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 2326607 30382903096047

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown