BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 18738844 · Received February 20, 2024

    Report

    Report Number
    1213809-2024-00093
    Event Type
    Malfunction
    Date Received
    February 20, 2024
    Date of Event
    October 3, 2023
    Report Date
    January 30, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    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

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. IT WAS REPORTED THE FLUID IS BACKFLOWING. TO AID IN THE INVESTIGATION, FOUR HUNDRED 3ML SYRINGES IN SEALED PACKAGING BLISTERS FROM LOT 0253185, WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. THE SAMPLES WERE TESTED FOR LEAKAGE PAST THE STOPPER BY AN INTERNAL PRESSURE TESTING PROCEDURE. OF THE FOUR HUNDRED SAMPLES, TEN WERE OBSERVED TO LEAK UNDER PRESSURE. EACH SYRINGE THAT LEAKED WAS MEASURED FOR BARREL DIAMETER AND THE RESULTS WERE ACCEPTABLE. THE PLUNGER RODS WERE EXAMINED WITH NO VISIBLE DEFECTS BEING NOTED. IN EIGHT OF THE TEN DEFECTIVE SAMPLES, THE STOPPERS WERE SLIGHTLY JAMMED OR INSECURE. THIS CONDITION IS NON-CONFORMING PER PRODUCT SPECIFICATION AND ASSOCIATED WITH THE ASSEMBLY PROCESS. IMPROPER ASSEMBLY FROM POOR LUBRICATION OF THE BARREL OR STOPPER, OR POOR PLUNGER TO STOPPER INSERTION CAN INDUCE THE INSECURE OR JAMMED STOPPERS AND LEAKAGE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309657, LOT 0253185. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. LOT 0253185 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. ROBUST CONTROLS TO DETECT THIS TYPE OF DEFECT ARE IN PLACE IN THE WAY OF IN-PROCESS ASSEMBLY INSPECTIONS AT SEVERAL PRE-DETERMINED TIME INTERVALS AND THERE ARE SILICONE WEIGHT AND DISTRIBUTION CHECKS THROUGHOUT THE BATCH. MACHINE LOGS, PRODUCTION DATABASES, SYRINGE SUB-ASSEMBLY AND MOLDING LOTS WERE ALL REVIEWED WITH NO RELEVANT NOTES OR DEFECTS FOUND. THIS CONDITION IS APPEARING AT OR BELOW ITS EXPECTED FREQUENCY; THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. 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

    POST INVESTIGATION FINDINGS REVEALED THAT THE STOPPER WAS JAMMED/INSECURE RESULTING IN LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FLUID WAS BACKFLOWING INTO THE PLUNGER." VERBATIM: PLEASE SEE THE ATTACHED DOCUMENT FOR SOME CUSTOMER RETURNS AS DEFECTIVE I NEED TO RETURN FOR CREDIT. WE HAVE ALREADY CREDITED OUR CUSTOMERS. CAN YOU PLEASE ISSUE RA¿S. ITEM#: 309657 LOT#: 0253185 PO#: (B)(4) FLUID IS BACKFLOWING RESPONSE RECEIVED ON 06-OCT-2023: I AM NOT SURE WHAT THE ADDRESS BELOW IS. I AM LOCATED AT: XXXXX I DO NOT HAVE ANY ADDITIONAL INFORMATION ON THIS RETURNED PRODUCT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    377484 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 0253185 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown