BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BD LUER-LOK

    MDR report key: 20577091 · Received October 31, 2024

    Report

    Report Number
    1213809-2024-00780
    Event Type
    Malfunction
    Date Received
    October 31, 2024
    Date of Event
    October 7, 2024
    Report Date
    January 17, 2025
    Manufacturer
    BECTON DICKINSON MEDICAL SYSTEMS
    Product Code
    FMF
    UDI-DI
    30382903095811
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 309581 AND LOT NUMBER 4221232. THE REVIEW DID NOT REVEAL ANY DETECTED ABNORMALITIES DURING THE PRODUCTION PROCESS THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT AND ALL QUALITY TESTS WERE FOUND TO BE WITHIN SPECIFICATION. AS NEITHER PICTURE NOR PHYSICAL SAMPLES WERE AVAILABLE, A THOROUGH ANALYSIS COULD NOT BE COMPLETED. IT IS POSSIBLE THAT THE ¿JELLY LIKE SUBSTANCE¿ OBSERVED IN THE SYRINGE 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 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. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.

    Description of Event or Problem · 0

    MATERIAL#: 309581, BATCH NUMBER#: 4221232. IT WAS REPORTED THAT THE BD LUER-LOK HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. CALLER STATES SHE HAS A BOX OF 3ML, SYRINGE/NEEDLE LUER LOCK COMBO, 309581 LOT 4221232. SHE STATES, SHE CAN SEE "A JELLY LIKE SUBSTANCE, IN THE SYRINGE. WHEN YOU PULL THE, PLUNGER BACK ITS LIKE STRINGY."

    Description of Event or Problem · 0

    NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848669 BD LUER-LOK PISTON SYRINGE FMF BECTON DICKINSON MEDICAL SYSTEMS 4221232 30382903095811

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown