BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYRINGE 30ML LL BNS

    MDR report key: 22888465 · Received August 25, 2025

    Report

    Report Number
    1911916-2025-00612
    Event Type
    Malfunction
    Date Received
    August 25, 2025
    Date of Event
    August 11, 2025
    Report Date
    August 25, 2025
    Manufacturer
    BECTON DICKINSON
    Product Code
    FMF
    UDI-DI
    50382903010337
    PMA / PMN Number
    K110771
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ACTUAL DATE OF EVENT IS UNKNOWN. THE DATE RECEIVED BY MANUFACTURER WAS ENTERED INTO THE DATE OF EVENT FIELD. DEVICE EVALUATION: MOISTURE AND CONDENSATION WERE REPORTED WITHIN THE SYRINGE. TO SUPPORT THE INVESTIGATION, FIFTY-THREE SAMPLES AND TWO PHOTOGRAPHS WERE SUBMITTED FOR EVALUATION BY THE QUALITY TEAM. THE SAMPLES WERE RECEIVED IN TEN SEPARATE BAGS, WITH THE FOLLOWING LOT NUMBERS AND QUANTITIES: FIVE SAMPLES FROM LOT 5043967; TEN SAMPLES FROM LOTS 4172676 AND 4212994; THREE SAMPLES FROM LOT 5079444; FOUR SAMPLES FROM LOT 5003386; FIVE SAMPLES FROM LOT 5062989; FIVE SAMPLES FROM LOT 5003389; THREE SAMPLES FROM LOT 5043778; FIVE SAMPLES FROM LOT 5043969; FIVE SAMPLES FROM LOT 5043964; AND EIGHT SAMPLES FROM LOT 5043965. A VISUAL INSPECTION WAS CONDUCTED ON ALL SAMPLES. NO DEFECTS, IMPERFECTIONS, MOISTURE, OR CONDENSATION WERE OBSERVED. ADDITIONALLY, NO EXCESS SILICONE LUBRICANT WAS NOTED. ONE OF THE SUBMITTED PHOTOGRAPHS SHOWS A SYRINGE WITH THE PLUNGER ROD AND RUBBER STOPPER FULLY DEPRESSED, REVEALING VISIBLE SILICONE LUBRICANT. THE SECOND PHOTOGRAPH DISPLAYS LUBRICANT ON THE LOWER PORTION OF THE SYRINGE BARREL WITH THE PLUNGER ROD AND RUBBER STOPPER RETRACTED. NO FURTHER INFORMATION COULD BE OBTAINED FROM THE IMAGES. THIS CONDITION OCCURS WHEN THE RUBBER STOPPER IS FULLY PRESSED TO THE BOTTOM OF THE SYRINGE BARREL, CAUSING THE MEDICAL-GRADE SILICONE LUBRICANT APPLIED TO THE INNER BARREL WALL AND STOPPER TO BECOME VISIBLE. A DEVICE HISTORY RECORD (DHR) REVIEW WAS COMPLETED FOR MATERIAL NUMBER 301033, COVERING THE FOLLOWING LOTS: 5043964, 5043965, 5043969, 5003389, 5043778, 5062989, 5003386, 5043967, 4172676, 5079444, AND 4212994. THE REVIEW DID NOT IDENTIFY ANY QUALITY ISSUES DURING PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED CONDITION. NO RELATED QUALITY NOTIFICATIONS WERE FOUND, AND ALL PROCESSES AND FINAL INSPECTIONS WERE IN COMPLIANCE WITH SPECIFICATION REQUIREMENTS. BASED ON THE INVESTIGATION AND ANALYSIS OF THE PHOTOGRAPHIC EVIDENCE, THE REPORTED CONDITION WAS CONFIRMED BUT DETERMINED TO BE ACCEPTABLE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

    Description of Event or Problem · 0

    IT IS REPORTED FOREIGN MATTER. EVENT DESCRIPTION: CUSTOMER CALLED THRU THERMOFISHER TO REPORT THAT THEY HAVE SEEN MOISTURE AND CONDENSATION ON SYRINGE - 301033 LOT NO 5043964, 5043965 AND 5043969, 5003389, 5043778, 5062989, 5003386, 5043967, 4172676, 4212994, SAMPLES AVAILABLE, NO USED ON PT, NO PT HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1484250 SYRINGE 30ML LL BNS SYRINGE, PISTON FMF BECTON DICKINSON 5079444 50382903010337

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown