BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 20601324 · Received November 4, 2024

    Report

    Report Number
    1213809-2024-00786
    Event Type
    Malfunction
    Date Received
    November 4, 2024
    Date of Event
    October 10, 2024
    Report Date
    June 19, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    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

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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). - SUPPLEMENTAL MDR - LEAKAGE PAST STOPPER. AS NO PHYSICAL SAMPLE, VALID PART NUMBER OR LOT NUMBER WAS PROVIDED FOR EVALUATION BY OUR QUALITY ENGINEER TEAM, A COMPLETE INVESTIGATION COULD NOT BE PERFORMED. BASED ON THE LIMITED INVESTIGATION RESULTS, A CAUSE FOR THE REPORTED INCIDENT COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    (B)(4)- SUPPLEMENTAL MDR - LEAKAGE PAST STOPPER ADDITIONAL INFORMATION: LOT NUMBER PROVIDED. LOT 4123362, DEVICE MANUFACTURE DATE: 05/02/2024 SECTION D AND H UPDATED TO NEW INFORMATION. EVALUATION: EIGHT SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. ALL SAMPLES WERE TESTED, AND NO DEFECTS WERE FOUND. THE CONDITION OBSERVED IS ACCEPTABLE PER PRODUCT SPECIFICATION. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4123362. 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

    MATERIAL: 302995; LOT: UNKNOWN. IT WAS REPORTED THAT THE BD SYRINGE 10ML LL S/C 200 HAD LEAKAGE PAST THE STOPPER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER" VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. DATE: 10/10/2024 COMPLAINT NUMBER: (B)(4). ACCOUNT NUMBER: (B)(4). ACCOUNT NAME: FRESENIUS MEDICAL CARE CANADA. CONTACT PERSON: (B)(6) ITEM NUMBER: (B)(4). SAMPLE AVAILABLE: CONFIRMING. LOT NUMBER: REQUESTING. PICTURES: REQUESTING IF AVAILABLE. ITEM DESCRIPTION: SYRINGE ONLY BD 10ML LUER LOCK. INCIDENT DESCRIPTION: AS PER ACCOUNT (B)(4), PATIENT ADVISES THAT WHEN USING THE SYRINGES AT ABOUT 20% THEY LET IN LITTLE STREAKS OF BLOOD WHICH NEVER USED TO HAPPEN ON OLD ONES. NO OTHER ISSUES OR PERFORMANCE ISSUES.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    790275 LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4123362 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown