BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 18503242 · Received January 12, 2024

    Report

    Report Number
    1213809-2023-01534
    Event Type
    Malfunction
    Date Received
    January 12, 2024
    Date of Event
    December 22, 2023
    Report Date
    June 5, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096054
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    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

    SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION. PLEASE NOTE IT IS POSSIBLE THE FM/¿WHITE RESIDUE¿ OBSERVED IN THE SYRINGE IS SILICONE. 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.

    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: "I HAVE A QUESTION FROM MY TEAM REGARDING THE RESIDUE ON THE BUTTON OF THE PLUNGERS. SOME OF THE SYRINGES HAVE A WHITE RESIDUE SO VISIBLE THAT WE HAD TO REJECT THEM FOR QUALITY. IS THERE AN EXPLANATION AS TO WHAT COULD THAT BE, OR WHAT IS USED THAT LEAVES THIS BEHIND ON THE PLUNGER."

    Description of Event or Problem · 0

    MATERIAL#: 309605, LOT#: 3152758. IT WAS REPORTED BY THE CUSTOMER REPORTED I HAVE A QUESTION FROM MY TEAM REGARDING THE RESIDUE ON THE BUTTON OF THE PLUNGERS. SOME OF THE SYRINGES HAVE A WHITE RESIDUE SO VISIBLE THAT WE HAD TO REJECT THEM FOR QUALITY. IS THERE AN EXPLANATION AS TO WHAT COULD THAT BE, OR WHAT IS USED THAT LEAVES THIS BEHIND ON THE PLUNGER. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. QUESTION REGARDING SYRINGE CONVENIENCE TRAY, LUER-LOK¿ TIP 10 ML BD309605. I HAVE A QUESTION FROM MY TEAM REGARDING THE RESIDUE ON THE BUTTON OF THE PLUNGERS. SOME OF THE SYRINGES HAVE A WHITE RESIDUE SO VISIBLE THAT WE HAD TO REJECT THEM FOR QUALITY. IS THERE AN EXPLANATION AS TO WHAT COULD THAT BE, OR WHAT IS USED THAT LEAVES THIS BEHIND ON THE PLUNGER?

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1845583 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3152758 30382903096054

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown