BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD SYRINGE 10ML LL S/C 200

    MDR report key: 21410122 · Received February 19, 2025

    Report

    Report Number
    1213809-2025-00108
    Event Type
    Malfunction
    Date Received
    February 19, 2025
    Date of Event
    January 22, 2025
    Report Date
    March 17, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903029953
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) - SUPPLEMENTAL MDR - SILICONE VISIBLE TWO SAMPLES AND ONE PHOTO WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. SILICONE IS VISIBLE ON BOTH STOPPERS, ALTHOUGH IT IS NOT POOLING OR STRINGING; THEREFORE, ACCEPTABLE. THE PHOTO IS A CLOSE-UP IMAGE OF ONE LOOSE SYRINGE FOCUSED ON THE STOPPER WITH SILICONE VISIBLE. FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS WAS PERFORMED AND CONFIRMS THE SUBSTANCE TO BE SILICONE USED IN THE MANUFACTURING PROCESS. THE CONDITION OBSERVED IS ACCEPTABLE PER PRODUCT SPECIFICATION. SILICONE IS AN INERT, NON-TOXIC MEDICAL SUBSTANCE USED AS A LUBRICANT FOR DISPOSABLE HYPODERMIC PRODUCTS. IT IS AN INTEGRAL PART OF THE SYRINGE, ENABLING IT TO PERFORM AS REQUIRED IN VARIOUS CLINICAL APPLICATIONS AND DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE NOR DOES IT IMPACT PRODUCT FUNCTION. SILICONE HAS BEEN IN USE IN THIS APPLICATION FOR OVER 20 YEARS, WITH ESTIMATED DISTRIBUTION WELL IN EXCESS OF 25 BILLION UNITS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. PLEASE SEE SILICONE QUANTITY GUIDELINE ATTACHED. THE REPORTED DEFECT WAS NOT IDENTIFIED IN THE SAMPLES RECEIVED. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 3348429 AND 4093635. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Additional Manufacturer Narrative · 0

    D.4. OTHER LOT NUMBER INCLUDES 3348429 AND OTHER EXPIRATION DATE INCLUDES 2028-11-30. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. OTHER LOT NUMBER DEVICE MANUFACTURE DATE IS 2023-12-14.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 0

    MATERIAL # 302995. BATCH # 3348429, 4093635. IT WAS REPORTED THAT THE BD SYRINGE 10ML LL S/C 200 HAD VISIBLE SILICONE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. BD 10CC SYRINGES. CATALOG: 302995. LOTS: 3348429, 4093635. WE HAVE FOUND THAT THESE SYRINGES HAVE EXCESS LUBRICANT INSIDE THE PLUNGER (SEE IMAGE). WE HAVE NOTICED THIS ISSUE IN THE FOLLOWING LOTS (3348429, 4093635). AT (B)(6), WE USE THESE SYRINGES FOR MANUFACTURING CELLULAR THERAPY PRODUCTS AND THIS EXCESS LUBRICANT CAN BE HARMFUL TO OUR PRODUCTS. BELOW IS A BREAKDOWN OF QUANTITY AFFECTED PER LOT: LOT# 3348429: (B)(4) EACH. LOT# 4093635: (B)(4) EACH. ADDITIONAL INFORMATION PROVIDED: 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT (MM-DD-YYYY) FOR EACH LOT 3348429, 4093635? A. 01-22-2025. 2. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. A. NO PATIENT HARM. THE SYRINGES WITH EXCESS LUBRICANT WERE NOT USED. 3. ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? A. YES, WE HAVE A SAMPLE. B. (B)(6). C. IF POSSIBLE, CAN WE RECEIVE THE RETURN LABEL VIA EMAIL?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2571303 BD SYRINGE 10ML LL S/C 200 PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4093635 30382903029953

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown