BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 21416073 · Received February 19, 2025

    Report

    Report Number
    1213809-2025-00115
    Event Type
    Malfunction
    Date Received
    February 19, 2025
    Date of Event
    October 11, 2024
    Report Date
    March 18, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095750
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PR (B)(4) - SUPPLEMENTAL MDR - SYRINGE NEEDLE CONNECTIVITY ISSUE. ONE SAMPLE FROM BATCH 4152464 AND TWO SAMPLES FROM BATCH 4184699 WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE REPORTED DEFECT WAS NOT OBSERVED IN THE SAMPLES RECEIVED. THE SAMPLES WERE ALSO LEAK TESTED FOR LEAKAGE AT LUER AND FOUND TO BE ACCEPTABLE. THE CONDITION OBSERVED IS ACCEPTABLE PER PRODUCT SPECIFICATION. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED BATCH NUMBERS 4152464 AND 4184699. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    D.4. OTHER LOT NUMBER INCLUDES 4152464 AND OTHER EXPIRATION DATE INCLUDES 2029-05-31. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. OTHER LOT NUMBER DEVICE MANUFACTURE DATE IS 2024-05-31.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED

    Description of Event or Problem · 0

    MATERIALS: 309575, BATCH#: 4152464,4184699. IT WAS REPORTED THAT THE BD LUER-LOK HAS A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RCC RECEIVED A COMPLAINT VIA EMAIL. PLEASE PROVIDE THE DATE OF EVENT: OCTOBER 11TH, 2024. PLEASE DESCRIBE THE ISSUE IN MORE DETAIL? THE SYRINGE NEEDLE IS FOUND TO NOT BE FULLY TWISTED INTO THE SECURED POSITION IN THE SYRINGE CAP. THE NEEDLE REQUIRES TWISTING WITH THE CAP TO SECURELY ATTACH IT TO THE BARREL. EVEN WITH TWISTING, THE NEEDLES MAY DETACH. THE CAP SOMETIMES DOES NOT EASILY LOCK, EVEN AFTER TAPPING IT CLOSED. PLEASE PROVIDE THE BATCH#: OR LOT#: NUMBER? 4152464 AND 4184699. PLEASE PROVIDE THE MATERIAL#: OR REF#: NUMBER? 309575 SYRINGE, STERILE, 3 ML, 21G X 1 IN NEEDLE PLEASE SHARE THE CAPTURED PHOTO OF THE EVENT IF AVAILABLE: NOT AVAILABLE ANY SAMPLE AVAILABLE FOR INVESTIGATION? SAMPLES ARE AVAILABLE FOR BOTH LOT NUMBERS. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT: THE ISSUE WAS NOT PATIENT RELATED. THERE WAS NO HARM TO PATIENT. THE ISSUE WAS DISCOVERED PRIOR TO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1192218 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4184699 30382903095750

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown