BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 24847573 · Received April 11, 2026

    Report

    Report Number
    1213809-2026-00193
    Event Type
    Malfunction
    Date Received
    April 11, 2026
    Date of Event
    March 23, 2026
    Report Date
    May 26, 2026
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    00382903096282
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). - SUPPLEMENTAL MDR - LEAKAGE OTHER. 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. 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. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT BD SYRINGE 1ML LL HAD LEAKAGE. VERBATIM: COMPLAINT VIA EMAIL. WE HAVE RECEIVED A QUALITY COMPLAINT ON PRODUCT SOLD TO OUR CUSTOMER. INJURIES OR ADVERSE EVENT: NO. ITEM: 309628. QUANTITY AFFECTED: 3BX. SERIAL/LOT NUMBER: SYRINGE: LOT # 535602817, NEEDLE: LOT # 304115. PO: (B)(4). ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. ARE SAMPLES POTENTIALLY CONTAMINATED OR BIOHAZARD? NO. REPORTED ISSUE: I HEARD TODAY FROM ONE OF OUR PROVIDERS THAT SOME OF THE 1CC SYRINGES HAVE BEEN LEAKING WHERE THE NEEDLE JOINS WITH THE SYRINGE. THIS HAPPENS WHEN THEY ARE DOING BOTOX TREATMENTS. HE IS NOT SURE IF IT IS THE SYRINGE OR THE NEEDLE. CUSTOMER DISPOSITION REQUEST: REPLACEMENT. THE EVENT OCCURRED ON 03/23/2026. I AM OUT OF THE OFFICE UNTIL NEXT WEEK SO I DON'T HAVE ACCESS TO THE PRODUCT BUT I CAN DOUBLE CHECK LOT NUMBERS THEN. ALSO, I AM NOT CLEAR ABOUT SHIPPING DEFECTIVE PRODUCT AS THEY WERE USED ON PATIENTS AND CONTAIN MEDICATION AND THE NEEDLES HAVE BEEN USED. I CAN TRY TESTING A FEW WITH SALINE AND SEND YOU THOSE. BUT, AGAIN I WON'T BE IN THAT OFFICE UNTIL SOMETIME NEXT WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    372251 LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 5356028 00382903096282

    Patients

    Seq Age Sex Outcome Treatment
    1