BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 21096664 · Received January 7, 2025

    Report

    Report Number
    1213809-2024-01038
    Event Type
    Malfunction
    Date Received
    January 7, 2025
    Date of Event
    November 25, 2024
    Report Date
    January 16, 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
    NY, 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

    (B)(6). FOLLOW UP MDR FOR DEVICE EVALUATION. THREE PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. TWO PHOTO SHOWS DIFFERENT CLOSE-UP VIEWS OF A FULLY ASSEMBLED, LOOSE SYRINGE WITH A COMPLETELY BROKEN COLLAR, COMPROMISING THE SYRINGE'S INTEGRITY. THE THIRD IMAGE PARTIALLY DEPICTS A DAMAGED BARREL WITH A BROKEN COLLAR AND A SECTION OF A NEEDLE HUB PROTECTED BY A SHIELD. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. THE POTENTIAL ROOT CAUSE FOR THE DAMAGED BARREL COULD NOT BE DETERMINED FROM THE PHOTO PROVIDED. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION. THE LOT NUMBER IS UNKNOWN, THEREFORE DEVICE HISTORY RECORD REVIEW (DHR) OR QUALITY NOTIFICATION REVIEW (QN) COULD NOT BE PERFORMED.

    Description of Event or Problem · 0

    MATERIAL # 309628. BATCH # 3122722. IT WAS REPORTED THAT THE BD LUER-LOK LUER WAS CRACKED / DAMAGED / DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. ¿THE REPORTER STATED THAT THE "THE TIP OF THE SYRINGE BROKE OFF" DURING PREPARATION¿. CATALOG #: 309628. LOT #: 3122722.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1321411 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3122722 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown