BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD 10ML SYRINGE LUER-LOK¿ TIP

    MDR report key: 15474417 · Received September 23, 2022

    Report

    Report Number
    1213809-2022-00626
    Event Type
    Malfunction
    Date Received
    September 23, 2022
    Date of Event
    August 29, 2022
    Report Date
    September 26, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION SUMMARY: TWO PHOTOS AND FOUR CONVENIENCE TRAYS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, SEVERE DAMAGES WERE OBSERVED. POTENTIAL ROOT CAUSE FOR THE DAMAGED TRAY DEFECT COULD NOT BE CONFIRMED TO HAVE ORIGINATED AT THE MANUFACTURING FACILITY. IT COULD BE POSSIBLE THAT SHIPPING AND HANDLING DAMAGE OCCURRED TO THE OUTER CARTON RENDERING THE PRODUCT UNUSABLE. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1200427. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. H3 OTHER TEXT : SEE H10.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD 10ML SYRINGE LUER-LOK¿ TIP EXPERIENCED WERE RECEIVED DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE SEVERAL DAMAGED TRAYS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT 4 BD 10ML SYRINGE LUER-LOK¿ TIP EXPERIENCED WERE RECEIVED DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE SEVERAL DAMAGED TRAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2728868 BD 10ML SYRINGE LUER-LOK¿ TIP PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 309605 1200427 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown