BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 21127128 · Received January 10, 2025

    Report

    Report Number
    1213809-2024-01045
    Event Type
    Malfunction
    Date Received
    January 10, 2025
    Date of Event
    December 18, 2024
    Report Date
    February 27, 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
    BE
    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

    (B)(4). SUPPLEMENTAL MDR/CORRECTION - SCALE MARKING ISSUE. CORRECTION: BATCH 3677737 IS INVALID LOT, CHANGED TO UNKNOWN. DEVICE EVALUATION: TWO PHOTOS OF 1 ML LL SYRINGES WERE RECEIVED AND EVALUATED. THE FIRST PHOTO SHOWS TWO LOOSE SAMPLES HELD BY SOMEONE'S FINGERS WITH GLOVES ON. THE BOTTOM SYRINGE APPEARS TO HAVE A SMEAR ON THE 0.7 MINOR GRAD LINES, WHILE THE TOP SYRINGE SEEMS TO HAVE A CRACKED BARREL, THOUGH THIS IS UNCLEAR FROM THE PHOTO. THE SECOND PHOTO DISPLAYS THREE LOOSE SYRINGES; THE FIRST TWO SYRINGES APPEAR TO HAVE CRACKS EXTENDING FROM THE 0.9 MARK DOWNWARD, AND THE THIRD SYRINGE SHOWS A LARGE SMEAR, AFFECTING A SIGNIFICANT SECTION OF THE NON-SCALE MARKING AREA. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED. A PHYSICAL SAMPLE IS REQUIRED FOR A THOROUGH EVALUATION AND ROOT CAUSE DETERMINATION FOR CRACKED BARRELS AND MISSING PLUNGER.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DURING UNPACKING OF MAT. 309648 - 309628 / BATCH 4243174 (SYRINGE, LL,3PART, 1CC (EXT) PALLET NR. 1004532074), WE NOTICED THAT SOME OF THE SYRINGES HAD POOR PRINTING. PLEASE SEE PICTURES OF THESE SYRINGES ATTACHED. OTHER SYRINGES WERE MISSING PLUNGERS AND WERE CONSIDERED DEFECTIVE. PLEASE INVESTIGATE WHY THIS ISSUE OCCURRED IN THE ABOVE BATCH AND PLEASE PROVIDE US WITH CORRECTIVE ACTIONS. THANK YOU FOR YOUR SUPPORT AND PLEASE REACH OUT IF YOU NEED MORE INFORMATION. ADDITIONAL INFORMATION PROVIDED: ¿ COULD YOU PLEASE PROVIDE THE LOT OF THE DEFECTIVE PRODUCT? 3677737 ¿ COULD YOU PLEASE PROVIDE A DATE OF EVENT? (B)(6) 2024 ¿ COULD YOU PLEASE CONFIRM IF ANY SAMPLES ARE AVAILABLE FOR INVESTIGATION? IF YES, PLEASE SPECIFY IF THE SAMPLES ARE: NO.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    513345 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS UNKNOWN 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown