BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 20518037 · Received October 23, 2024

    Report

    Report Number
    1213809-2024-00752
    Event Type
    Malfunction
    Date Received
    October 23, 2024
    Date of Event
    September 26, 2024
    Report Date
    January 8, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP REPORT FOR CORRECTION AND DEVICE EVALUATION. THE EVENT/PRODUCT PROBLEM WAS INCORRECT IN THE INITIAL MDR. CORRECT EVENT/PRODUCT PROBLEM IS STOPPER JAMMED / INSECURE. INVESTIGATION SUMMARY: TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. UPON PHOTOS EVALUATION, IT WAS OBSERVED THAT ONE SYRINGE IN A SEALED PACKAGE WITH 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. THESE CONDITIONS ARE OCCURRING BELOW THEIR EXPECTED FREQUENCY, SO NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3011963. 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 #: 309628 BATCH#: 3011963 IT WAS REPORTED THAT THE BD LUER-LOK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. "ON DOS XXXXX XXX HAD TO USE ANOTHER SYRINGE DUE TO THE ONE THAT CAME IN THE MED WAS DAMAGED."

    Description of Event or Problem · 0

    POST INVESTIGATION FINDINGS REVEALED THAT THE FOREIGN MATTER WAS ACTUALLY STOPPER JAMMED / INSECURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2581600 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3011963 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown