BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 50ML LL

    MDR report key: 19575822 · Received June 20, 2024

    Report

    Report Number
    3003152976-2024-00361
    Event Type
    Malfunction
    Date Received
    June 20, 2024
    Date of Event
    June 14, 2024
    Report Date
    November 7, 2024
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    00382903008650
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4) FOLLOW UP MDR FOR DEVICE EVALUATION: FOUR PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, SILICONE CAN BE SEEN WITHIN THE SYRINGE. LUBRICANT IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS TO HELP FACILITATE MOVEMENT OF THE PLUNGER AND STOPPER. THE SILICONE EMPLOYED IN THIS PRODUCT IS A MEDICAL GRADE SILICONE AUTHORIZED FOR PRODUCT USE. SILICONE CONTENT TESTS ARE PERFORMED DURING THE MANUFACTURING PROCESS OF EACH LOT NUMBER. RESULTS WERE REVIEWED FOR LOT 2110041 AND WERE FOUND TO BE WITHIN SPECIFICATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 2110041, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. SIX RETAINED SAMPLES WERE USED FOR ADDITIONAL EVALUATION. ALL PRODUCT WAS INSPECTED, NO EVIDENCE OF SILICONE WAS OBSERVED WITHIN THE SYRINGES AND SILICONE CONTENT TESTING CONFIRMED THE PRODUCT MET REQUIRED SPECIFICATIONS. WITHOUT THE PHYSICAL SAMPLE, WE CANNOT VERIFY THE SILICONE CONTENT IS WITHIN SPECIFIED LIMITS. BASED ON OUR INVESTIGATION WE CANNOT IDENTIFY A SPECIFIC CAUSE RELATED TO THE MANUFACTURING PROCESS. DUE TO THE VISCOSITY OF THE LUBRICANT, IT IS POSSIBLE TO SEE EVIDENCE OF IT WHEN MOVING THE STOPPER FROM BEING FULLY SEATED AT THE TOP OF THE SYRINGE, THIS DOES NOT INDICATE THAT THE SILICONE IS IN EXCESS. A PROJECT HAS BEEN INITIATED TO REVIEW OUR SILICONE PROCESS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL BE MONITORED BY OUR QUALITY TEAM FOR SIGNS OF EMERGING TRENDS.

    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

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    WHEN CUSTOMER OPENING OF THE STERILE PACKAGE, IT HAS BEEN IDENTIFIED THAT THERE IS AN OILY SUBSTANCE ON THE INSIDE OF THE SYRINGE. THIS WAS RECOGNISED WHEN A TEXIUM (ALSO STERILE) TRIED TO BE ATTACHED AND IT UNTHREADED ON ITS OWN DUE THE OILY SUBSTANCE. DETAILS: ITEM: 300865, 2021-10-01, 2026-09-30, BATCH: 2110041. GCUH ONCOLOGY PHARMACY COMPOUNDING CURRENTLY HAS 33 OF THIS BATCH ON HAND HOWEVER WE ARE UNABLE TO IDENTIFY HOW MANY QUEENSLAND HEALTH WAREHOUSE WOULD HAVE ON HAND.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2155867 SYRINGE 50ML LL SYRINGE, PISTON FMF BECTON DICKINSON 2110041 00382903008650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown