BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 3ML LL 200 S/C

    MDR report key: 23306320 · Received October 15, 2025

    Report

    Report Number
    9614033-2025-00097
    Event Type
    Malfunction
    Date Received
    October 15, 2025
    Date of Event
    August 14, 2025
    Report Date
    November 25, 2025
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    INVESTIGATION RESULTS: THE CLAIM IS CLASSIFIED AS UNCONFIRMED SINCE THE CUSTOMER DID NOT PROVIDE PHYSICAL SAMPLES OR PHOTOGRAPHS TO PERFORM THE ANALYSIS AND DETERMINE THE TYPE OF DEFECT. HOWEVER, A WALKTHROUGH OF THE MOLDING PROCESS WAS CARRIED OUT AND RULED OUT AS A CAUSE, AS IT WAS FOUND TO BE OPERATING UNDER OPTIMAL CONDITIONS. IN THE ASSEMBLY PROCESS, IT WAS IDENTIFIED THAT DURING THE CYLINDER¿PLUNGER¿STOPPER STAGE, SOME NOZZLES WERE DAMAGED AND MISALIGNED. THIS WAS DUE TO THE ORIGINAL DESIGN, WHICH CAUSED DAMAGE TO THE CYLINDER TIP; THEREFORE, IT CAN BE CONSIDERED A POTENTIAL CAUSE BASED ON THE CUSTOMER¿S DESCRIPTION. ACTIONS HAVE BEEN IMPLEMENTED TO MITIGATE THIS DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD SYRINGE 3ML LL 200 S/C LUER WAS CRACKED / DAMAGED / DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL #:309657 BATCH#:4261606, 4319903, 4319917, 4232220, 4291326, 5008054. VERBATIM: THIS FOR BD 3ML SYRINGE REF# (B)(4), (B)(6) # (B)(4). THIS MAY BE ON A MANUFACTURER DEFECT LEVEL. WE ARE FINDING THAT THE BARREL OF THE SYRINGE IS WARPED TOWARD THE TIP OF THE SYRINGE. THIS IS CAUSING MEDICATIONS DURING INJECTIONS TO STOP HAVING TO RE-STICK PATIENTS. I HAVE FOUND THAT IT IS AFFECTING ALL CURRENT LOTS THAT WE HAVE ON HAND. THIS IS CAUSING MEDICATIONS DURING INJECTIONS TO STOP HAVING TO RE-STICK PATIENTS. I HAVE COLLECTED THE XXX BRAND 3ML SYRINGES #(B)(4) BETWEEN ALL OF MY LOCATIONS AND AM USING A DIFFERENT BRAND. I HAVE 48 BOXES IN TOTAL. HERE ARE THE LOT# THAT WE HAVE: 4261606. 4319903. 4319917. 4232220. 4291326. 5008054.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2736995 BD SYRINGE 3ML LL 200 S/C PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 4291326 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown