BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DROPLET SYRINGE

    MDR report key: 22035431 · Received May 16, 2025

    Report

    Report Number
    3014312726-2025-00004
    Event Type
    Malfunction
    Date Received
    May 16, 2025
    Date of Event
    January 8, 2025
    Report Date
    July 16, 2025
    Manufacturer
    SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA.
    Product Code
    FMF
    UDI-DI
    00818392018035
    PMA / PMN Number
    K153537
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON THE ANALYSIS OF HTL/DROPLET 1ML INSULIN SYRINGE 30G 12.5MM REF 6007, LOT 0220601, THERE IS NO EVIDENCE OF QUALITY ISSUES ASSOCIATED WITH THIS COMPLAINT. NO SAMPLES/PICTURES OR OTHER EVIDENCE OF IMPACTED PRODUCT WAS RECEIVED FROM THE CUSTOMER FOR EVALUATION OF THE REPORTED ISSUE. HOWEVER, FOR CONTINUOUS IMPROVEMENT, THE POTENTIAL ROOT CAUSE WEAS DETERMINED TO BE MISSED INSPECTION. DURING THE INSPECTION PROCESS, THE INSPECTION OPERATORS FAILED TO PROMPTLY FIND AND ELIMINATE DEVICES WHERE THE CAP AND THE BARREL WERE SLIGHTLY OFFSET DURING POINT SEALING, CAUSING THE POINT SEALING POSITION TO BE LESS THAN IDEAL. AS CORRECTIVE ACTION, PACKAGING AND INSPECTION OPERATORS WILL BE RETRAINED ON THE INTERNAL "CLEARANCE OPERATION INSTRUCTION" DOCUMENT, FOCUSING ON ISOLATING AND SCRAPPING DEFECTIVE PRODUCTS. SOL MILLENNIUM WILL CONTINUE TO MONITOR THIS KIND OF ISSUE AND IN CASE THE NUMBER OF COMPLAINTS INCREASES, FURTHER EVALUATION AND CORRECTIVE ACTIONS WILL BE TAKEN. THIS REPORT WAS INITIALLY SUBMITTED ON 01/13/2025. DUE TO ISSUES WITH DISPLAYING THE INITIAL SUBMISSION, THIS SUBMISSION CONTAINS BOTH INITIAL AND SUPPLEMENTAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS REPORT WHEN INITIALLY SUBMITTED ENCOUNTERED AN INTERNAL ISSUE POTENTIALLY RELATED TO DATABASE CONNECTIVITY. THIS ISSUE WAS IDENTIFIED WHILE IMPLEMENTING CAPA-57 WHICH WAS OPENED FOLLOWING AN FDA INSPECTION. THIS SUPPLEMENTAL MDR IS BEING SUBMITTED TO CORRECT THE BRAND NAME PROVIDED IN THE INITIAL MDR [3014312726-2025-00004]. THE PREVIOUSLY REPORTED BRAND NAME WAS INCORRECT. THE CORRECT BRAND NAME IS DROPLET SYRINGE.

    Description of Event or Problem · 0

    CUSTOMER REPORTED THAT THEY ARE HAVING ISSUES WITH THE ORANGE CAPS ON THE SYRINGE FALLING OFF EXPOSING THE USER END OF THE NEEDLE. CUSTOMER HAS BEEN POKED MORE THAN ONCE BECAUSE OF THIS PROBLEM. NO SERIOUS INJURY OUTSIDE OF A MINOR POKE WHILE RETRIEVING THE SYRINGE PRIOR TO INJECTION ATTEMPT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1088978 DROPLET SYRINGE HTL/DROPLET 1ML INSULIN SYRINGE 30G * 12.5MM FMF SOL-MILLENNIUM MEDICAL INC., CHICAGO, IL, USA. 6007 02206017 00818392018035

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown