BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK¿ SYRINGE

    MDR report key: 15084665 · Received July 22, 2022

    Report

    Report Number
    1213809-2022-00411
    Event Type
    Malfunction
    Date Received
    July 22, 2022
    Date of Event
    June 22, 2022
    Report Date
    August 3, 2022
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    PMA / PMN Number
    K110771
    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

    DATE OF EVENT IS UNKNOWN; AWARENESS DATE HAS BEEN USED FOR THIS FIELD. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.9. DEVICE AVAILABLE FOR EVAL: YES. D.9. RETURNED TO MANUFACTURER ON: 20-JUL-2022. H.6. INVESTIGATION SUMMARY: TWO SAMPLES AND TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE SAMPLES WERE VISUALLY INSPECTED WITH A 30X MICROSCOPE. THE NEEDLE HUBS HAVE A SHORT SHOT THAT INDUCED THE SYMPTOM REPORTED. BD DETERMINED THAT THE CAUSE OF THE FAILURE WAS ASSOCIATED WITH THE MOLDING PROCESS OF THE PRODUCT. VERIFICATION OF THE MOLDING PROCESS WAS PERFORMED AND THE SETTINGS WERE CORRECT. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 1160642. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE MEDICATION WAS LEAKING AT THE LUER CONNECTION WHEN DRAWING UP THE VACCINE. CUSTOMER REPORTED WHEN DRAWING UP VACCINE, MEDICATION WAS LEAKING AT LUER CONNECTION. THIS OCCURRED ON (B)(6) 2022 AND OTHER UNKNOWN DATES. SAME CAT AND LOT NUMBER.

    Description of Event or Problem · 0

    IT WAS REPORTED WHILE USING BD LUER-LOK¿ SYRINGE LEAKAGE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE MEDICATION WAS LEAKING AT THE LUER CONNECTION WHEN DRAWING UP THE VACCINE. CUSTOMER REPORTED WHEN DRAWING UP VACCINE, MEDICATION WAS LEAKING AT LUER CONNECTION. THIS OCCURRED ON 06/21/2022 AND OTHER UNKNOWN DATES. SAME CAT AND LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555506 BD LUER-LOK¿ SYRINGE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 1160642

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown