BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 18223483 · Received November 28, 2023

    Report

    Report Number
    9614033-2023-00131
    Event Type
    Malfunction
    Date Received
    November 28, 2023
    Date of Event
    October 31, 2023
    Report Date
    February 26, 2024
    Manufacturer
    BECTON DICKINSON DE MEXICO
    Product Code
    FMF
    UDI-DI
    00382903033102
    PMA / PMN Number
    K151766
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: PHOTO AND FOUR SAMPLES RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT CAN BE OBSERVED THAT THE SYRINGE IS LUBRICATED WITH WHAT APPEARS TO BE AN EXCESSIVE AMOUNT OF SILICONE. FOURIER TRANSFORM INFRARED SPECTROSCOPY WAS PERFORMED, CONFIRMING THE FOREIGN SUBSTANCE AS SILICONE. QUANTIFICATION OF SILICONE PERFORMED ON THE SAMPLES WERE NOT WITHIN SPECIFICATION. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT 3012143, NO DEVIATIONS OR NON-CONFORMANCES WERE IDENTIFIED DURING THE MANUFACTURING PROCESS THAT COULD HAVE CONTRIBUTED TO THIS ISSUE. LUBRICANT IS EMPLOYED DURING THE SYRINGE ASSEMBLY PROCESS TO LUBRICATE THE CYLINDERS IN THE SILICONE STATION. 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 3012143 2AND FOUND TO BE WITHIN SPECIFICATION. POSSIBLE ROOT CAUSE IS DUE TO A FAILURE IN THE SPRAYER THAT DOSES THE SILICONE INSIDE THE BARRELS. MANUFACTURING PERSONNEL HAVE BEEN NOTIFIED OF THIS INCIDENT AND MAINTENANCE PLAN FOR THE INJECTION SYSTEM WILL BE COMPLETED EVERY SIX MONTHS.

    Additional Manufacturer Narrative · 0

    H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION RECEIVED

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK SYRINGES CONTAINED FOREIGN MATTER. THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: "REPORTED ISSUE: STICKY FILM." ARE ANY SAMPLES AVAILABLE FOR RETURN? YES. ADDITIONAL INFORMATION RECEIVED ON 11/07/2023. PLEASE PROVIDE OCCURRENCE DATE. (B)(6) 2023 IS THERE ANY ADVERSE EVENT ON PATIENT? NO. ADDITIONAL INFORMATION RECEIVED ON 11/08/2023: CLARIFY INCIDENT, WHAT IS MEANT BY "STICKY FILM"? WET SUBSTANCE IN APPEARANCE, WHEN TOUCHED FEELS STICKY, FEELS LIKE RESIDUE THAT MAY BE FROM THE RUBBER? WHERE IS THE "STICKY FILM" LOCATED? LOCATED ON THE BLACK RUBBER PART OF THE INSIDE OF THE SYRINGE WHAT COLOR? NO COLOR, SIZE? (COATS THE BLACK RUBBER PART) (SEE PICTURE PROVIDED WAS THERE ANY HARM TO THE PATIENT/CAREGIVER? (DETAIL) NO, BUT IS QUESTIONABLE SINCE THE SYRINGE IS USED FOR DRAWING UP MEDICATIONS THAT ARE GIVEN VIA INTRAVENOUS ROUTE TO PATIENTS. WAS THE REPORTED INCIDENT NOTICED BEFORE, DURING OR AFTER USE? NOTICED BY THE NURSE ANESTHETIST BEFORE DRAWING UP MEDICATIONS FOR PATIENT. WAS THERE EXPOSURE TO BLOOD OR CHEMOTHERAPY TO MUCOUS MEMBRANES OR SKIN? (DETAIL) NO. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO THE INCIDENT (IMAGING TESTS, SURGERY, MEDICATION ADMINISTRATION, ETC.)? (DETAIL) NO.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601966 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 3012143 00382903033102

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown