BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 18592107 · Received January 26, 2024

    Report

    Report Number
    9614033-2024-00005
    Event Type
    Malfunction
    Date Received
    January 26, 2024
    Date of Event
    December 22, 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
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION SUMMARY: PHOTO RECEIVED BY OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT CAN BE OBSERVED THAT THE SYRINGE IS LUBRICATED WITH WHAT APPEARS TO BE A LUBRICANT THAT COULD BE SILICONE. PHYSICAL SAMPLES ARE REQUIRED TO FURTHER ANALYZE AND IDENTIFY THE LUBRICANT. A DEVICE HISTORY REVIEW WAS PERFORMED FOR REPORTED LOT (B)(6) , 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 (B)(6) AND FOUND TO BE WITHIN SPECIFICATION. WHILE WE CANNOT IDENTIFY A DIRECT ISSUE, 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: IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK SYRINGE CONTAINED FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD A RECENT ISSUE WITH LUBRICANT CONDENSATION IN THE BD 20 ML LUER LOK SYRINGE. I'VE TAKEN A LOOK AT ALL THE SYRINGES AND IT APPEARS THAT IT MIGHT BE A PRODUCT-SPECIFIC RATHER THAN THE LOT-SPECIFIC PROBLEM. ALL THE SYRINGES HAVE THE SAME REF: #303310 WITH 6 DIFFERENT LOT #S: (3012142, 3012143, 3012140, 2339636, 2339628, AND 2339624)." ADDITIONAL INFORMATION PROVIDED ON 01/10/2024.: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? UNKNOWN. NONE REPORTED. WAS THERE A DELAY OF, OR CHANGE IN, THE COURSE OF TREATMENT DUE TO THE EVENT? UNKNOWN. NONE REPORTED. ANY SAMPLE OR PHOTO AVAILABLE FOR INVESTIGATION? NOT AVAILABLE. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? UNKNOWN. NONE REPORTED. HOW WAS TREATMENT COMPLETED FOR CUSTOMER? UNKNOWN. NONE REPORTED. PATIENT STATUS? UNKNOWN. NONE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    796601 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON DE MEXICO 2339624 00382903033102

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown