BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 20ML LL BNS

    MDR report key: 22020292 · Received May 14, 2025

    Report

    Report Number
    1911916-2025-00345
    Event Type
    Malfunction
    Date Received
    May 14, 2025
    Date of Event
    May 1, 2025
    Report Date
    June 10, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    50382903010313
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP FOR DEVICE EVALUATION: AN INVESTIGATION WAS INITIATED FOLLOWING REPORTS OF EMBEDDED MATTER IN THE SYRINGE TIP, THREADS ON THE PLUNGERS, AND A PLASTIC FRAGMENT INSIDE THE TIP. TO SUPPORT THE EVALUATION, FORTY-NINE SAMPLES WERE SUBMITTED IN THREE LABELED PLASTIC BAGS, ALONG WITH THREE PHOTOGRAPHS. THE QUALITY TEAM CONDUCTED A THOROUGH ASSESSMENT OF THE MATERIALS RECEIVED. THE FIRST BAG, LABELED ¿THREAD ON THE PLUNGER,¿ CONTAINED FIVE SAMPLES. THESE SAMPLES EXHIBITED A PLASTIC FLASH AT THE GATE VESTIGE, WHICH WAS AFFIXED TO THE PLUNGER ROD. THIS CONDITION IS CONSIDERED ACCEPTABLE AND DOES NOT CONSTITUTE A DEFECT. THE SECOND BAG, LABELED ¿EMBEDDED MATTER,¿ INCLUDED SIX SAMPLES. THESE SYRINGES CONTAINED DARK-COLORED SPECKS IDENTIFIED AS EMBEDDED DEGRADED RESIN. THIS TYPE OF CONTAMINATION TYPICALLY OCCURS DURING THE STARTUP PHASE OR INTERMITTENTLY THROUGHOUT THE INJECTION MOLDING PROCESS, WHEN DEGRADED RESIN MAY DETACH AND BECOME INCORPORATED INTO MOLDED COMPONENTS. THE THIRD BAG, LABELED ¿FLASH ON TIP,¿ CONTAINED THIRTY-EIGHT SAMPLES. THESE UNITS DISPLAYED A PLASTIC FLASH AT THE SYRINGE BARREL LUER TIP. UPON MEASUREMENT, THE FLASH WAS FOUND TO BE WITHIN SPECIFICATION. THE ACCOMPANYING PHOTOGRAPHS PROVIDED VISUAL CONFIRMATION OF THE REPORTED CONDITIONS. NO ADDITIONAL DEFECTS OR ANOMALIES WERE OBSERVED DURING THE INSPECTION. A REVIEW OF THE DEVICE HISTORY RECORDS FOR MATERIAL NUMBER 301031, INCLUDING POTENTIAL LOT NUMBERS 3352762 AND 4080684, WAS COMPLETED. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES OR NONCONFORMANCES DURING PRODUCTION THAT COULD BE LINKED TO THE REPORTED CONDITIONS. ALL MANUFACTURING PROCESSES AND FINAL INSPECTIONS WERE PERFORMED IN ACCORDANCE WITH SPECIFICATION REQUIREMENTS, AND NO RELATED QUALITY NOTIFICATIONS WERE FOUND. BASED ON THE INVESTIGATION AND ANALYSIS OF THE SUBMITTED SAMPLES, THE REPORTED ISSUES HAVE BEEN CONFIRMED. THE EMBEDDED DEGRADED RESIN IS CONSISTENT WITH KNOWN MOLDING PROCESS BEHAVIOR, AND THE OTHER OBSERVED CONDITIONS FALL WITHIN ACCEPTABLE MANUFACTURING TOLERANCES.

    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.

    Description of Event or Problem · 0

    EMBEDDED MATTER (IN TIP): (B)(4) SYRINGES. EVENT DETAILS: WE HEREBY SUBMIT OUR FINDINGS AT THE END OF BATCH, AS AGREED UPON. ALL DEVIATIONS WERE FOUND DURING PACKAGING, PRIOR TO STERILIZATION. SO, PRIOR TO USE, SO NO MEDICATION AND NO PATIENTS ARE INVOLVED. DEVIATIONS: EMBEDDED MATTER (IN TIP): (B)(4) SYRINGES. THREAD ON PLUNGER: (B)(4) SYRINGES. PIECE OF PLASTIC ON INSIDE OF THE TIP: (B)(4) SYRINGES. IT¿S TOO SMALL TO BLOCK THE OPENING, AND IT IS ATTACHED TO SYRINGE. BUT THE POSITION OF THIS PIECE IS UNDESIRED. FYI: WE SAW THIS EXACT SAME DEVIATION ON A LARGE AMOUNT OF 50ML¿S, WHICH WE HAVE NOT SUBMITTED YET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1328557 SYRINGE 20ML LL BNS SYRINGE, PISTON FMF BECTON DICKINSON UNKNOWN 50382903010313

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown