BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 18044541 · Received October 31, 2023

    Report

    Report Number
    1213809-2023-01210
    Event Type
    Malfunction
    Date Received
    October 31, 2023
    Date of Event
    October 12, 2023
    Report Date
    November 21, 2023
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096573
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    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/¿FLUID/FILM¿ 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.

    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

    MATERIAL#: 309657. BATCH#: 3130978. IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS A FLUID/ FILM ON THE INSIDE OF THEIR 3ML SYRINGES (SKU #309657// LOT #3130978). VERBATIM: FOUND THAT THERE WAS A FLUID/ FILM ON THE INSIDE OF THEIR 3ML SYRINGES (SKU #309657// LOT #3130978).

    Description of Event or Problem · 0

    IT WAS REPORTED THE BD LUER-LOK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FOUND THAT THERE WAS A FLUID/ FILM ON THE INSIDE OF THEIR 3ML SYRINGES (SKU #(B)(4)// LOT #3130978).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2141785 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3130978 30382903096573

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown