BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 50ML LL BNS

    MDR report key: 23577674 · Received November 17, 2025

    Report

    Report Number
    1911916-2025-00747
    Event Type
    Malfunction
    Date Received
    November 17, 2025
    Date of Event
    November 6, 2025
    Report Date
    November 18, 2025
    Manufacturer
    BD MEDICAL (BD WEST) MEDICAL SURGICAL
    Product Code
    FMF
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). FOLLOW UP FOR DEVICE EVALUATION. IT WAS REPORTED THAT CONNECTING THE SYRINGE TO THE VALVE WAS DIFFICULT. TO SUPPORT THE INVESTIGATION, FIVE UNPACKAGED SAMPLES WERE RECEIVED FOR EVALUATION BY THE QUALITY TEAM. THREE SAMPLES WERE MARKED WITH HANDWRITTEN LOT NUMBER 4247506, ONE SAMPLE WAS LABELED WITH THE NUMBER ¿2,¿ AND ANOTHER WITH THE NUMBER ¿5.¿ A VISUAL INSPECTION REVEALED NO DEFECTS OR IMPERFECTIONS. EACH SYRINGE WAS THEN FILLED WITH SALINE SOLUTION, ASSEMBLED WITH A NEEDLE, AND TESTED. THE SALINE SOLUTION WAS EXPELLED WITHOUT LEAKS OR ANY ABNORMAL CONDITIONS. A DEVICE HISTORY RECORD REVIEW WAS CONDUCTED FOR MATERIAL NUMBER 301035, COVERING LOTS 3200836, 4122702, 4190340, 4247506, AND 5010903. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND, AND ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. TO DATE, NO SIMILAR EVENTS HAVE BEEN REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND ANALYSIS OF THE RETURNED SAMPLES, THE REPORTED SYMPTOM COULD NOT BE CONFIRMED.

    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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 50ML LL BNS HAD A SYRINGE NEEDLE CONNECTIVITY ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT 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. ADDITIONAL INFORMATION PROVIDED: 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 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1862692 BD SYRINGE 50ML LL BNS PISTON SYRINGE FMF BD MEDICAL (BD WEST) MEDICAL SURGICAL 5010903

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown