BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL NS

    MDR report key: 23584402 · Received November 18, 2025

    Report

    Report Number
    3003152976-2025-00634
    Event Type
    Malfunction
    Date Received
    November 18, 2025
    Date of Event
    June 5, 2025
    Report Date
    December 1, 2025
    Manufacturer
    BECTON DICKINSON, S.A.
    Product Code
    FMF
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DATE OF EVENT IS UNKNOWN. BD AWARENESS DATE USED. INITIAL MDR, IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: IT WAS REPORTED THAT THERE WERE DIFFICULTIES CONNECTING THE SYRINGES TO A CONNECTING VALVE. TWO SAMPLES WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. VISUAL INSPECTION REVEALED MINOR DAMAGE TO THE THREAD, SUGGESTING THAT THE CONNECTION MAY HAVE BEEN FORCED DURING ASSEMBLY. THE THREAD FUNCTIONALITY WAS EVALUATED BY CONNECTING THE SYRINGE TO A NEEDLE, AND NO ISSUES WERE OBSERVED, CONFIRMING THAT THE THREAD REMAINED FUNCTIONAL. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED AND NO DEVIATIONS OR NONCONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONCERN. ADDITIONAL EVALUATION WAS PERFORMED USING RETAINED SAMPLES FROM AVAILABLE LOT. PRODUCTS UNDERWENT VISUAL INSPECTION, AND NO DAMAGE OR RELATED DEFECTS WERE OBSERVED. PRODUCTS FROM THIS MANUFACTURING LINE ARE ROUTINELY SUBJECTED TO VISUAL AND FUNCTIONAL INSPECTIONS DURING MULTIPLE STAGES OF PRODUCTION, INCLUDING TIP AND THREAD VERIFICATION, IN ACCORDANCE WITH ESTABLISHED PROCEDURES. RECORDS FOR THE REPORTED LOT WERE REVIEWED, AND NO FINDINGS RELATED TO THIS INCIDENT WERE IDENTIFIED. THE RETURNED SAMPLES, ALONG WITH RETAINED PRODUCTS, UNDERWENT THE SAME TESTING, AND ALL RESULTS CONFIRMED COMPLIANCE WITH REQUIRED SPECIFICATIONS. BASED ON OUR INVESTIGATION, WE ARE UNABLE TO DETERMINE A ROOT CAUSE LINKED TO OUR PRODUCTION PROCESS AT THIS TIME. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED FOR FUTURE OCCURRENCE.

    Description of Event or Problem · 0

    EVENT DETAILS: BD SYRINGES THAT WE BOUGHT, WE USE THEM TO INCLUDE THEM IN A CELL REGENERATION KIT. AND THESE LUER LOCK SYRINGES, WE CONNECT THEM DURING THE TECHNIQUE, TO A LUER LOCK VALVE. WE HAVE BEEN USING THE SAME SYRINGES AND VALVES FOR MANY YEARS, AT LEAST MORE THAN 5 YEARS. BUT IN THE LAST FEW MONTHS: THE NUMBER OF INCIDENTS REPORTED BY END USERS HAS INCREASED, RELATED TO THE DIFFICULTY TO CONNECT THE SYRINGE TO THE VALVE. INTERNALLY, DURING THE PRODUCTION PROCESS, WE CHECK 100% OF ASSEMBLIES TO LUBRICATE A RESERVOIR CONTAINING THE KIT. WHERE THE ASSEMBLY IS LEFT READY FOR THE TECHNIQUE. AND A COUPLE OF WEEKS AGO, THE OPERATORS ALSO TOLD US THAT IT WAS A LITTLE MORE DIFFICULT FOR THEM TO CARRY OUT THE JOINT. 27-OCT-2025: ADDITIONAL INFO RESPONSE RECEIVED. BOTH THE 20ML AND THE 50ML MODELS ARE CONNECTED TO A VALVE WITH A LUER LOCK CONNECTION, AND WHEN TRYING TO CONNECT THEM, THE CONNECTION OF THE SYRINGES DETERIORATES VERY EASILY, CAUSING THE CONNECTION TO BE UNSUCCESSFUL. COULD YOU PROVIDE THE DATE OF THE EVENT FOR EACH BATCH (3200836, 4122702, 4190340, 4247506, 5010903)? THE CLIENT CONFIRMS THAT THEY ARE ALL TAKEN PLACE IN 2025 BUT HAS NOT PROVIDED SPECIFIC DATES. WE HAVE INSISTED ON THIS INFORMATION; WE HOPE TO SHARE MORE DATA SOON. WAS THE PATIENT OR USER HARMED? IF YES, PLEASE EXPLAIN: PATIENT: YES, HE WAS HARMED. SYRINGES ARE USED TO TRANSPORT THE PATIENT'S BLOOD FROM THE EXTRACTION KIT TO THE PRP CYLINDER FOR CENTRIFUGATION. DUE TO CONNECTION FAILURES, BLOOD IS LOST AND A NEW VENIPUNCTURE IS NECESSARY. IN SOME CASES, THIS POTENTIALLY PREVENTS THE CELL REGENERATION TECHNIQUE FROM BEING APPLIED TO THE PATIENT. USER (HEALTHCARE PROFESSIONAL): IT HAS ALSO BEEN AFFECTED, IN CERTAIN CASES. DURING FAILED CONNECTION ATTEMPTS, THERE MAY BE CONTACT WITH THE PATIENT'S BLOOD, WHICH IMPLIES A RISK OF EXPOSURE. COULD YOU CLARIFY WHETHER THE REPORTED CONNECTION ISSUES RESULTED IN LEAKS? WERE THERE ANY NEGATIVE CONSEQUENCES FOR THE PATIENT OR USER DUE TO THESE EVENTS?: YES, CONNECTION PROBLEMS CAUSED DEFORMATION OF THE SYRINGE'S LUER LOCK CONE, RESULTING IN BLOOD LEAKAGE. THESE LEAKS OCCURRED WHEN TRYING TO CONNECT THE SYRINGE WITH A LUER LOCK VALVE, WITHOUT SUCCESS, WHICH GENERATED BLOOD SPILLS AND POTENTIAL RISKS FOR BOTH THE PATIENT AND THE USER.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262174 SYRINGE 20ML LL NS SYRINGE, PISTON FMF BECTON DICKINSON, S.A. 2410004

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown