BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5 ML BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE

    MDR report key: 17924814 · Received October 12, 2023

    Report

    Report Number
    1213809-2023-01131
    Event Type
    Injury
    Date Received
    October 12, 2023
    Date of Event
    August 10, 2023
    Report Date
    February 13, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096337
    PMA / PMN Number
    K980987
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR 8990096 - FOLLOW UP MDR FOR DEVICE EVALUATION. IT WAS REPORTED THERE WAS A LEAKAGE ISSUE. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309633, LOT 3060178. THE REVIEW REVEALED ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. LOT 3060178 WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED CORRECTIVE ACTIONS ARE NOT NECESSARY. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. 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.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED 5 ML BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE WAS LEAKING. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: REPORTED ISSUE: LEAKING; (B)(6) 2023. ON (B)(6) 2023 ONE OF OUR MEDICAL ASSISTANTS WAS DRAWING UP LIDOCAINE USING THE 5ML (B-D309577 SYRINGE, 21G X 1.5", NEEDLE COMBO) WHEN INSTEAD OF DRAWING INTO THE SYRINGE SOME OF THE LIDOCAINE CAME SQUIRTING OUT THE SIDE OF THE NEEDLE WHERE THE NEEDLE ATTACHES TO THE SYRINGE (GREEN PART). THE NEEDLE WAS SECURELY ATTACHED TO THE SYRINGE. THE LIDOCAINE WENT INTO HER EYE REQUIRING IT TO BE FLUSHED OUT. SHE HAD IRRITATION AND NUMBNESS TO HER EYE AND SURROUNDING TISSUE FOR SEVERAL HOURS AFTER THE INCIDENT. I PROMPTLY REPORTED THE INCIDENT TO MEDLINE TO BRING AWARENESS TO A POSSIBLE PRODUCT DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2134075 5 ML BD LUER-LOK¿ SYRINGE WITH ATTACHED NEEDLE PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3060178 30382903096337

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| O