BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 19478944 · Received June 6, 2024

    Report

    Report Number
    1213809-2024-00343
    Event Type
    Malfunction
    Date Received
    June 6, 2024
    Date of Event
    May 13, 2024
    Report Date
    August 21, 2024
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903096283
    PMA / PMN Number
    K941562
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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

    TEN SAMPLES OF 1 ML LL SYRINGES (P/N 309628) WERE RECEIVED AND EVALUATED. ALL SAMPLES WERE RECEIVED LOOSE AND PRESENTED EXCESSIVE SILICONE STRINGING BETWEEN THE ROOF OF THE BARREL AND PAST THE STOPPER. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. SAMPLES WERE SENT TO THE VERNON HILLS FACILITY FOR FTIR ANALYSIS, AND THE TEST RESULTS CONFIRMED THAT THE SUBSTANCE PRESENT WAS 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. IT DOES NOT PRESENT A SAFETY OR EFFICACY ISSUE, NOR DOES IT IMPACT PRODUCT FUNCTION. SILICONE HAS BEEN USED IN THIS APPLICATION FOR OVER 20 YEARS, WITH AN ESTIMATED DISTRIBUTION OF MORE THAN 25 BILLION UNITS. NO REPORTS ARE KNOWN OF ADVERSE CLINICAL EFFECTS ASSOCIATED WITH THESE PRODUCTS AND THE UNINTENTIONAL DELIVERY OF SILICONE FLUID LUBRICANT. POTENTIAL ROOT CAUSE FOR THE EXCESSIVE SILICONE DEFECT IS ASSOCIATED WITH THE ASSEMBLY PROCESS. THESE CONDITIONS ARE OCCURRING AT/BELOW THEIR EXPECTED FREQUENCY. THEREFORE, NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3212106 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE BD LUER-LOK HAD VISIBLE SILICONE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "EXCESS SILICONE IN THE PLUNGER SO IT APPEARS SYRINGES ARE LEAKING."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13000 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 3212106 30382903096283

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown