BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 22720363 · Received August 5, 2025

    Report

    Report Number
    1213809-2025-00523
    Event Type
    Malfunction
    Date Received
    August 5, 2025
    Date of Event
    July 20, 2025
    Report Date
    August 30, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903029952
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4). BARREL CRACKED. SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT. NO ROOT CAUSE CAN BE DETERMINED AS NO SAMPLES WERE RECEIVED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. ALL VISUAL INSPECTIONS WERE PERFORMED AS PER REQUIREMENT WITH NO QUALITY NOTIFICATIONS RELATED TO THE COMPLAINT DEFECT. BATCH WAS INSPECTED AND ACCEPTED BASED ON MEETING OUR INSPECTION CONTROL PLAN AND SUBSEQUENTLY APPROVED FOR SHIPMENT. 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 THAT THE BD SYRINGE 10ML LL S/C 200 BARREL WAS CRACKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 302995. BATCH # 5022505. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. AHS MDIP REPORT INCIDENT OR PROBLEM INFORMATION. AHS MDIP REFERENCE NUMBER (ID): (B)(4). DATE OF INCIDENT: (B)(6) 2025. SITE NAME/LOCATION: (B)(6). LEVEL OF HARM: CLOSE CALL - CAUGHT BY CHANCE. AHS OPTIONAL REPORT TO CMDSNET (HEALTH CANADA): INCIDENT DETAILS: DURING PATIENT INTUBATION WRITER WAS ADMINISTERING MEDICATIONS VIA IV PUSH, WHEN WRITER WAS ORDERED TO ADMINISTER ROCURONIUM WRITER NOTICED THAT THE SYRINGE WAS LEAKING. WRITER ATTEMPTED TO REATTACH THE SYRINGE TO IV PORT BUT THE MEDICATION CONTINUED TO LEAK, IT WAS THEN OBSERVED THAT THERE WAS A HAIRLINE CRACK IN THE 10CC SYRINGE CAUSING SOME OF THE MEDICATION TO LEAK OUT INSTEAD OF GOING TO THE PATIENT. DEVICE INFORMATION: DEVICE NAME/DESCRIPTION: SYRINGE LUER LOCK TIP 10ML. MANUFACTURER: BECTON DICKINSON CANADA INC. MANUFACTURER CODE/MODEL: 302995. SERIAL OR LOT NUMBER: (B)(6). DEVICE EXPIRY DATE: 2029-12-31. SUPPLIER: SUPPLIER CATALOGUE NUMBER: 308-302995. WAS THE DEVICE RETAINED? NO.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2633196 LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5022505 00382903029952

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown