BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUER-LOK

    MDR report key: 22100502 · Received May 28, 2025

    Report

    Report Number
    1911916-2025-00382
    Event Type
    Malfunction
    Date Received
    May 28, 2025
    Date of Event
    May 21, 2025
    Report Date
    June 25, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    30382903028307
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP, MOISTURE WAS REPORTED INSIDE SOME SYRINGES PRIOR TO OPENING. AS NO PHYSICAL SAMPLE WAS RETURNED, A COMPREHENSIVE EVALUATION COULD NOT BE CONDUCTED. HOWEVER, THREE PHOTOGRAPHS WERE PROVIDED AND REVIEWED BY OUR QUALITY TEAM TO SUPPORT THE INVESTIGATION. ONE IMAGE DEPICTED TWO PACKAGING BLISTER TOP WEBS, WHILE THE REMAINING TWO SHOWED A SYRINGE WITH VISIBLE DROPLETS AT THE BOTTOM OF THE BARREL. NO ADDITIONAL INSIGHTS COULD BE DERIVED FROM THE PHOTOGRAPHS. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR MATERIAL NUMBER 302830, LOT 5090131. THE REVIEW FOUND NO QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD BE LINKED TO THE REPORTED CONDITION. THERE WERE NO ASSOCIATED QUALITY NOTIFICATIONS, AND ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS. TO DATE, NO SIMILAR INCIDENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE PHOTOGRAPHIC EVIDENCE, THE REPORTED CONDITION HAS BEEN CONFIRMED. HOWEVER, IN THE ABSENCE OF A PHYSICAL SAMPLE, IT IS NOT POSSIBLE TO DETERMINE A PROBABLE ROOT CAUSE.

    Additional Manufacturer Narrative · 0

    (B)(6) FOLLOW UP: A DEVICE HISTORY RECORD REVIEW WAS COMPLETED BY OUR QUALITY ENGINEER TEAM FOR PROVIDED MATERIAL NUMBER 302830 AND LOT NUMBER 5090131. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THIS DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS A SAMPLE WAS UNAVAILABLE FOR RETURN, A THOROUGH SAMPLE INVESTIGATION COULD NOT BE COMPLETED. BASED ON THE INVESTIGATION RESULTS, AN EXACT CAUSE FOR THIS INCIDENT COULD NOT BE IDENTIFIED. SHOULD YOU AGAIN EXPERIENCE ANY PROBLEMS WITH OUR PRODUCT WE WOULD APPRECIATE THE OPPORTUNITY TO CONDUCT A THOROUGH ANALYSIS. THERE ARE QUALITY CONTROLS CURRENTLY IN PLACE TO DETECT THIS TYPE OF DEFECT DURING THE PRODUCTION PROCESS. FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY AT THIS TIME.

    Description of Event or Problem · 0

    MATERIAL#: 302830. BATCH#: 5090131. IT WAS REPORTED BY THE CUSTOMER THAT ONE OF THE OR NURSES NOTICED THAT SOME SYRINGES HAD SOME MOISTURE ACCUMULATED ON THE INSIDE OF THE SYRINGE PRIOR TO BEING OPENED. VERBATIM: GOOD MORNING, I WANTED TO REACH OUT TO YOU ABOUT OUR BD SYRINGES, TODAY ONE OF THE OPERATING ROOM NURSES NOTICED THAT SOME SYRINGES HAD SOME MOISTURE ACCUMULATED ON THE INSIDE OF THE SYRINGE PRIOR TO BEING OPENED. THE PACKAGING WAS INTACT AND ARE STORED IN STERILE STORAGE. PLEASE LET ME KNOW YOUR RECOMMENDATIONS, THANK YOU.

    Description of Event or Problem · 0

    WE PULLED WHAT WE HAD WITH THAT LOT NUMBER, SOME HAVING MORE MOISTURE IN THEM THAN OTHERS. I WOULD SAY AT LEAST 50% OF THE 216 HAD MOISTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    362114 LUER-LOK SYRINGE, PISTON FMF BECTON DICKINSON 5090131 30382903028307

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown