BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 19281702 · Received May 9, 2024

    Report

    Report Number
    1213809-2024-00280
    Event Type
    Malfunction
    Date Received
    May 9, 2024
    Date of Event
    April 22, 2024
    Report Date
    May 21, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION.

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    MATERIAL: 309605 BATCH#: 3152764. IT WAS REPORTED BY THE CUSTOMER THAT THEY HAVE CRACKED SYRINGE. VERBATIM: HELLO, WHAT IS THE STATUS OF THESE COMPLAINTS? IF CLOSED, PLEASE EMAIL ME THE REPORT. DATE COMPANY VENDOR REFERENCE # COMPLAINT # PRODUCT PRODUCT PART # PRODUCT LOT # COMPLAINT/ISSUE 10/25/2023 BD (B)(4) STERILE SYRINGE TRAY 10ML #309605 / EXPIRY 5-31-2028 3152764 CRACKED SYRINGE - 1 THANK YOU, ADDITIONAL INFORMATION RECEIVED ON 30-APR-2024. I CAN¿T FIND AN ORIGINAL COMMUNICATION THAT I WOULD HAVE PROVIDED TO BD FOR THIS COMPLAINT. DATE OPENED AND DOCUMENTED I NOTICED BD IS 10/25/23. THE ATTACHED PDF IS A DRAFT OF THE PRODUCT COMPLAINT CREATED TO-DATE.

    Description of Event or Problem · 0

    MATERIAL: 309605 BATCH#: 3152764.IT WAS REPORTED THAT THE BD LUER-LOK SYRINGE BARREL CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CRACKED SYRINGE" VERBATIM: HELLO, WHAT IS THE STATUS OF THESE COMPLAINTS? IF CLOSED, PLEASE EMAIL ME THE REPORT. DATE COMPANY VENDOR REFERENCE # COMPLAINT # PRODUCT PART # PRODUCT LOT # COMPLAINT/ISSUE (B)(6) 2023 BD (B)(4) STERILE SYRINGE TRAY 10ML #309605 / EXPIRY (B)(6) 2028 3152764 CRACKED SYRINGE - 1 THANK YOU, ADDITIONAL INFORMATION RECEIVED ON 30-APR-2024 I CAN¿T FIND AN ORIGINAL COMMUNICATION THAT I WOULD HAVE PROVIDED TO BD FOR THIS COMPLAINT. DATE OPENED AND DOCUMENTED I NOTICED BD IS 10/25/23. THE ATTACHED PDF IS A DRAFT OF THE PRODUCT COMPLAINT CREATED TO-DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1331280 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3152764 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown