BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 19563886 · Received June 18, 2024

    Report

    Report Number
    1213809-2024-00388
    Event Type
    Malfunction
    Date Received
    June 18, 2024
    Date of Event
    June 8, 2024
    Report Date
    December 6, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096467
    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. D.4. OTHER LOT NUMBER INCLUDES 4100276 AND OTHER EXPIRATION DATE INCLUDES 2029-03-31. 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 2024-04-09.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS; ONE SAMPLE AND ONE PHOTO WERE RECEIVED BY OUR QUALITY TEAM AND EVALUATED. THE SAMPLE RECEIVED AS ONE LOOSE SYRINGE WITH ALL COMPONENTS SEPARATED HAS THE STOPPER DEFORMED ON ONE SIDE CONSISTENT WITH BEING JAMMED. THE PHOTO SHOWS A CLOSE-UP IMAGE OF ONE LOOSE SYRINGE WITH THE STOPPER JAMMED BETWEEN THE BARREL AND THE PLUNGER ROD. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION; THEREFORE, THE REPORTED INCIDENT IS VERIFIED. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF EITHER OF THE BATCHES. BASED ON OUR QUALITY TEAM'S INVESTIGATION, THE POTENTIAL ROOT CAUSE FOR THE STOPPER JAMMED DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.

    Description of Event or Problem · 0

    MATERIALS#: 309646 BATCH#: 4100276 OR 4018994. IT WAS REPORTED THAT THE BD LUER-LOK STOPPER WAS DEFECTIVE/DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHILST COMPOUNDING TODAY WE FOUND A DEFECTIVE 5ML SYRINGE ¿ AS YOU CAN SEE IT APPEARS THAT THE STOPPER IS BENT ON ONE END. THE PLUNGER MOVES FREELY - THE STOPPER DOES NOT IMPEDE MOVEMENT BUT IT DOES APPEAR MELTED PERHAPS. WE AREN¿T SURE EXACTLY WHAT LOT THIS IS FROM BUT IT IS MOST LIKELY 4100276 EXPIRY 2029-03-31 -OR- 4018994 EXPIRY 2028-12-31."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    640801 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4018994 30382903096467

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown