BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 18007487 · Received October 25, 2023

    Report

    Report Number
    1213809-2023-01174
    Event Type
    Malfunction
    Date Received
    October 25, 2023
    Date of Event
    September 18, 2023
    Report Date
    November 21, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. E4. THE INITIAL REPORTER ALSO NOTIFIED THE FDA ON ( 18-SEP-2023). MEDWATCH REPORT IS (ENTER REPORT NUMBER).

    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. H3 OTHER TEXT : SEE H10 MANUFACTURE NARRATIVE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK SYRINGE HAD A SCALE MARKING ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "SYRINGE IS BLANK, NO VOLUME SCALE ON SIDE."

    Description of Event or Problem · 0

    MATERIAL#: (B)(4) BATCH: 3111348. IT WAS REPORTED BY CUSTOMER THAT SYRINGE IS BLANK, NO VOLUME SCALE ON SIDE. VERBATIM: COMPLAINT RECEIVED VIA EMAIL. EMAIL(S) ATTACHED. . BECTON DICKSON PLASITPAK 3ML SYRINGE, (B)(4), LOT3111348 SYRINGE IS BLANK, NO VOLUME SCALE ON SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1838539 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3111348 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown