BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 20457652 · Received October 15, 2024

    Report

    Report Number
    1213809-2024-00717
    Event Type
    Malfunction
    Date Received
    October 15, 2024
    Date of Event
    September 13, 2024
    Report Date
    February 19, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    FOUR SAMPLES AND TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. FOUR SAMPLES WERE RECEIVED. HOWEVER, DUE TO THE CONTAMINATED CONDITION OF THE SAMPLES, PHOTOS HAVE BEEN TAKEN AND EVALUATED. THE FIRST PHOTO SHOWS LOOSE SYRINGE FILLED WITH AN UNKNOWN WHITE FLUID, BUT NO FOREIGN MATTER CAN BE CONFIRMED FROM THE PHOTO. THE SECOND PHOTO DEPICTS A SECTION OF A LOOSE SYRINGE FILLED WITH AN UNKNOWN TRANSPARENT LIQUID WITH UNKNOWN FOREIGN MATERIAL IN THE FLUID PATH, SPECIFICALLY ON THE STOPPER. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION; HOWEVER, AN UNUSED PHYSICAL SAMPLE WOULD BE IDEAL FOR IDENTIFYING THE TYPE OF FOREIGN MATTER PRESENT IN THE SAMPLE PROVIDED. THE POTENTIAL ROOT CAUSE FOR FOREIGN MATTER IN THE FLUID PATH IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4061598. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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

    MATERIAL#: 309605 BATCH#: 4061598 IT WAS REPORTED THAT THE BD LUER-LOK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED DID WE FILE A COMPLAINT WITH BD FOR LOT 4061598 10 ML SYRINGES ¿ PARTICLES IN SYRINGES? WE HAD 3 BATCHES IN A ROW WITH THAT LOT BEFORE WE SWITCHED OUT. ADDITIONAL INFO: 1. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. NONE AT THIS TIME. 2. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? TWO DATES: 11-SEP-2024, 13-SEP-2024 3. CAN YOU PLEASE PROVIDE THE ALL 3 LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? THIS WAS A SINGLE LOT, WITH MULTIPLE SYRINGES FOUND WITH PARTICLES. THE FIRST USE WAS A SINGLE SYRINGE, AND THE SECOND USE WAS 3 SYRINGES. 4. TOTAL NUMBER OF OCCURRENCES? TWO 5. ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? THE PERSON WHO WOULD KNOW IS OUT OF THE OFFICE TODAY. SHE RETURNS TOMORROW AND WE WILL REPLY AGAIN. 6. IF POSSIBLE, COULD YOU PLEASE PROVIDE PICTURE SAMPLES FOR INVESTIGATION? TWO EXAMPLES ATTACHED. 7. WHETHER PARTICLES FOUND IN THE FLUID PATH? FOUND IN THE BARREL AND UNDERNEATH THE PLUNGER SEAL. ADDITIONAL INFO: WE DO HAVE UNITS BUT THEY DO HAVE PRODUCT IN THEM. IS THAT AN ISSUE?

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353236 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4061598 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown