BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DROPLET

    MDR report key: 24814054 · Received April 8, 2026

    Report

    Report Number
    3014312726-2026-00027
    Event Type
    Malfunction
    Date Received
    April 8, 2026
    Date of Event
    December 8, 2025
    Report Date
    April 2, 2026
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC
    Product Code
    FMF
    UDI-DI
    00818392018059
    PMA / PMN Number
    K153537
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE INVESTIGATION, A REVIEW OF THE BATCH MANUFACTURING RECORDS AND TESTING PERFORMED ON RETAINED SAMPLES, INCLUDING VISUAL INSPECTION, LUMEN PATENCY, AND SIMULATION OF USE, DID NOT IDENTIFY ANY ABNORMALITIES, AND RESULTS WERE WITHIN APPLICABLE SPECIFICATIONS. EVALUATION OF THE RETURNED SAMPLES CONFIRMED THE PRESENCE OF INTERMITTENT LUMEN OBSTRUCTION (CLOGGED CANNULA). FTIR ANALYSIS IDENTIFIED THE MATERIAL AS SILICONE OIL. THE POTENTIAL ROOT CAUSE IS ASSOCIATED WITH VENTILATION CONDITIONS DURING THE SILICONIZATION PROCESS, WHICH MAY HAVE RESULTED IN INCOMPLETE REMOVAL OF EXCESS SILICONE OIL AND SUBSEQUENT ACCUMULATION WITHIN THE NEEDLE LUMEN. CORRECTIVE ACTIONS, INCLUDING ENHANCED CLEANING PROCEDURES FOR PRODUCTION CLAMPS AND OPERATOR TRAINING, WERE IMPLEMENTED IN DECEMBER 2024. THESE ACTIONS ARE INTENDED TO REDUCE THE LIKELIHOOD OF RECURRENCE. THE REPORTED LOT WAS MANUFACTURED PRIOR TO THE IMPLEMENTATION OF CORRECTIVE ACTIONS. AT THIS TIME, AVAILABLE DATA DO NOT INDICATE A WIDESPREAD OR INCREASING TREND FOR THIS FAILURE MODE. THE MANUFACTURER WILL CONTINUE TO MONITOR THIS ISSUE THROUGH POST-MARKET SURVEILLANCE PROCESSES AND TAKE FURTHER ACTION AS APPROPRIATE. FOLLOWING COMPLETION OF THE INVESTIGATION AND SUBSEQUENT INTERNAL REVIEW OF THE AVAILABLE INFORMATION, INCLUDING THE NATURE OF THE MALFUNCTION AND ITS POTENTIAL CLINICAL IMPACT, THE EVENT WAS DETERMINED TO MEET MDR REPORTING CRITERIA. THE MANUFACTURER WAS INFORMED THAT THE IMPORTER HAD ALSO SUBMITTED AN MDR FOR THIS EVENT.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THEY CURRENTLY USING SYRINGES FROM A DROPLET BOX, AND I'VE NOTICED A NUMBER OF DEFECTIVE SYRINGES AS OF LATE. I'VE NEVER SEEN THIS BEFORE AS I'VE BEEN A INSULIN DEPENDENT DIABETIC FOR QUITE A NUMBER OF YEARS NOW. I'M CURRENTLY USING 0.3 MM X 12.5 MM CAPACITY 3/10 ML/CC SYRINGES AND HAVE NOTICED A NUMBER OF THEM LATELY (MAYBE 30% TO 40%) HAVE HAD NEEDLES THAT SEEM TO BE BLOCKED. WHERE I WOULD INSERT THE NEEDLE INTO MY VIAL OF INSULIN AND IT TRY TO DRAW SOME INSULIN INTO THE SYRINGE, BUT I WOULDN'T GET ANY INTO THE NEEDLE AND THEN THE PLUNGER WOULD DROP TOWARDS THE BOTTOM OF THE SYRINGE. OBVIOUSLY, THE SYRINGE WAS UNDER VACUUM AND WOULDN'T DRAW ANY INSULIN INTO THE SYRINGE. I STARTED CHECKING ALL THE SYRINGES I WAS USING BY DRAWING IN AIR AND WAITING TO SEE IF THE PLUNGER WOULD STAY EXTENDED OR START DROPPING TOWARDS EMPTY BEFORE I INSERTED THEM INTO THE VIAL OF INSULIN, AND AS I SAID IN ABOUT 30% TO 40% HAVE BEEN DEFECTIVE AND I HAD TO DISCARD THEM. THE LOT NUMBER OF THE BOX IS 02408037 AND THESE WERE OBTAINED FROM CENTERWELL ONLINE PHARMACY. I DON'T KNOW WHAT YOUR COMPANY CAN OR WILL DO ABOUT THIS ISSUE, BUT I THOUGHT I'D AT LEAST BRING IT TO YOUR ATTENTION SINCE I NEED THESE FOR INSULIN DELIVERY 3 X DAILY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    472303 DROPLET HTL/DROPLET 0.3ML INSULIN SYRINGE 30G * 12.5MM (U-100 INSULIN ONLY)(PE BAG) FMF SOL-MILLENNIUM MEDICAL INC 6009 02408037 00818392018059

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male